U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
Reason
Beckman coulter has confirmed that non-reproducible falsely elevated test results may occur when using the access total bhcg assay. these elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range.
the role of preanalytical factors in laboratory testing has been described in a variety of published literature.
Action
Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:.
" Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results.
" Follow the sample handling instructions provided in the Access Total ¿hCG Instruction for Use (IFU).
" Review the enclosed pre-analytical sample handling information bulletins:
1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A).
2. Sample Handling Makes a Difference (P/N A28226A).
" At the discretion of the laboratory director, any total ¿hCG result that is questioned due to lack of clinical correlation should be repeated.
NOTE: Due to the clinical utility of the Access Total ¿hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¿hCG test results. The Access Total ¿hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician.
" Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation.
" Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received.
If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call
1-800-854-3633 in the United States and Canada. Outside the United States and Canada
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Multi-Analyte Controls - Product Code JJY
Reason
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Action
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Multi-Analyte Controls - Product Code JJY
Reason
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Action
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Multi-Analyte Controls - Product Code JJY
Reason
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Action
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Multi-Analyte Controls - Product Code JJY
Reason
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Action
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Multi-Analyte Controls - Product Code JJY
Reason
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Action
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@alere.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Pregnancy test - Product Code LCX
Reason
Lack of assurance of safety and efficacy: unapproved for marketing in the u.S., non-compliance with cgmp regulations and no stability data to support labeled expirations dates.
Action
Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product.
If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Neonate newborn screening card demographic and filter portion may be detached.
Action
The firm, Whatman, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions.
If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Angiotensin I and Renin Radioimmunoassay - Product Code CIB
Reason
The kit control provided with the gammacoat plasma renin activity kit was labeled with the incorrect range.
Action
Consignees were Emailed or faxed a "DiaSorin Customer Notification" letter dated October 21, 2009. The letter was addressed to "Dear Valued Customer". The letter described the Product name and the problem and provided the correct range for the Renin Activity Control provided with the kit. The letter also stated that replacement product for any previous failed runs. Customers are to complete the bottom portion of the letter and return it to the firm. Questions or concerns should be directed to DiaSorin Inc., Technical Services at
1-800-328-1482 or 651-439-9710.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
Results can elevate after sensor replacement. sodium urine
results can be falsely elevated 15 mmol/l within 24 hours after installation of a new sensor.
Action
The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
Results can elevate after sensor replacement. sodium urine
results can be falsely elevated 15 mmol/l within 24 hours after installation of a new sensor.
Action
The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
Results can elevate after sensor replacement. sodium urine
results can be falsely elevated 15 mmol/l within 24 hours after installation of a new sensor.
Action
The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
This recall was initiated because of software issue was identified in system software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument.
Action
Beckman Coulter issued an "Urgent: Product Corrective Action" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved.
For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
PORTABLE CLINICAL ANALYZER - Product Code CGA
Reason
The storage temperature on the label on the side of the i-stat portable clinical analyzer shipping box does not match product specification.
Action
An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
in vitro diagnostic lab workcell - Product Code CDT
Reason
Incorrect result: an intermittent low result may be seen with the last test run from an aliquot on a dimension vista system when connected to a streamlab analytical workcell. the sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). the surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.
Action
Siemens healthcare Diagnostics issued an Urgent Field Safety Notice letter to each customer regarding the issue dated September 2009. The letter informed the user of the problem and volume change instructions. Customers can call Technical Solutions Center at 800-441-9250
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
During manufacturing, two components of the architect i1000sr were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover.
Action
ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Reason
The recall was initiated after beckman coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. premature failure of the pump may negatively affect precision. the failure is limited to those unicel dxi 800, dxi 600, and dxc 880i systems which have a pump identified with one of the new pump manufacturing numbers (mfg. nos.) listed ab.
Action
Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible.
For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Calculator/data processing module, for clinical use - Product Code JQP
Reason
When an architect c16000 system is connected to an accelerator aps system, the software on the accelerator aps system may not generate an error warning when a sample presentation/sample queue error occurs, which could result in contamination of subsequent samples.
Action
Abbott Laboratories notified Customers of the affected device via a "Product Correction" letter dated October 27, 2008. Consignees provided with a temporary work around until a service representative upgrades the system software.
For further information, contact your local Abbott Laboratories, Inc. service representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ion Specific Potassium Electrode - Product Code CEM
Reason
Elevated range of potassium levels.
Action
The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The field action was initiated after an investigation for the total bilirubin reagents (list number 8g62 and list number 6l45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the diazo method. the matrix of this secondary standard caused a positive bias.
because of these findings, a new total bilirubin calibrator value assignm.
Action
On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions:
1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory;
2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet;
3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appropriate calibrator lot number and reagent list number.
ARCHITECT cSystems: Refer to System Configuration in Section 2, Installation Procedures and Special Requirements in the Architect System Operations Manual.
AEROSET: Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual;
4. Calibrate the Total Bilirubin assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory;
5. Evaluate your quality control. Shifts in quality control and proficiency testing samples may vary among laboratories and should be evaluated according to your laboratory procedures. NOTE: Refer to the Attachments (E and F) for the representative shift with the revised calibrator values (Patient sample and Control/QC recovery); and
6. Evaluate your reference range and any shifts in patient results. It is recommended that each laboratory established its own expected ranges, which may be unique to the population it serves.
Please retain this communication for future reference. If you have forwarded any Clinical Chemistry Bilirubin Calibrator to another laboratory, please provide a copy of this letter to them.
For questions, please contact ABBOTT Customer Service at 877-422-2688 (or 877-4ABBOTT). Customers outside of the
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Data processing module for clinical use - Product Code JQP
Reason
Sample problems; five issues identified related to software utilized by the accelerator aps system input/output module, to include: under three specific conditions, the post-aspiration radio-frequency identification (rf id) read of the tube carrier is not performed and the aps work cell may not appropriately generate sample presentation/sample queue errors with aps software version 1.1.1 or earlie.
Action
Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ion Specific Electrode (Sodium) - Product Code JGS
Reason
Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
Action
Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ion Specific Electrode (Sodium) - Product Code JGS
Reason
Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
Action
Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ion Specific Electrode (Sodium) - Product Code JGS
Reason
Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
Action
Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.