French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
Ortho Clinical Diagnostics withdraws from the market lot 1130 (per 08.09.04) of the in vitro diagnostic medical device called VITROS TROPONINE I - reference 194 9882, following some reports of false positive results (no report in France). This device is intended for the assay, on the VITROS analyzer, of cardiac Troponin I in heparinized human plasma.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Patients who use these products are advised to contact LifeScan to confirm that their meter is set up in the correct unit of measurement. In Brazil, patients can call the OneTouch Customer Service at 0800 701 5433 or visit www.onetouch.com.br. To better address this issue, LifeScan has temporarily discontinued the release of the Lifescan OneTouch Ultra Complete Glucose Determination System, which allows users to change the unit of measure. LifeScan is implementing a product change for its new OneTouch Ultra meters, which will prevent patients from inadvertently changing units of measurement. ANVISA through the Unit of Technovigilance will be accompanying the actions that will be carried out through the company with respect to the whole process of correction of said product. BRAZIL-15/06/2005 - Update - Lifescan is reviewing the user manual and operating instructions accompanying all related products (reagent tapes and control solution). In addition, although no product claims involving the unit of measurement have occurred in Brazil, all glucose monitors will be fabricated with the function locked for the option of manually changing the unit of measurement from mg / dL to mmo / L. the user will no longer have the option to program his monitor to obtain mmol / L result, which increases the safety of the product and minimizes the possibility of the user misinterpreting the glucose result.
Reason
Possible misinterpretation of blood glucose results.
Action
LifeScan, a Johnson & Johnson affiliated company, is worldwide announcing voluntary corrective action for some glucose meters./// Worldwide notification notice to all users of OneTouch Ultra Glucose meters regarding the possibility of misinterpreting blood glucose results. The company is conducting a worldwide notification program, which consists of letters to registered users and their healthcare professionals, as well as special instructions inserted into each pack of reagent strips.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
According to the company there is record of import and distribution of affected lots, and that the company has already started the collection process with its customers and that all affected products found in stock were blocked for sale and transferred to the quarantine site. which has already identified all the products located in stock and customers, for which the products in were sent, already having been sent the notice of collection. The UTVIG - Technovigilance Unit will be monitoring the entire collection process.
Reason
The ability of certain product units to provide negatively tendentious results at concentrations below 0.20ng / ml (μg / l), this failure may be reflected in negatively tending results that affect both patient samples and positive control fluid from low level. patients with very low concentrations of troponin i may be negatively tendentious and reported incorrectly as lower than the upper reference limit (url) of 0.08ng / ml (μg / l). results greater than 0.2 ng / ml (μg / l) are not affected by this failure.
Action
Statement of recollection; Request to customers to discard the remaining inventory of the lots in question.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The US FDA has sent a letter of communication to Anvisa informing about a Class 1 recall alert, issued in that country, involving the product ARCHITECT STAT TROPONINA-I REAGENT. The diagnostic test in question is used to quantify Troponin-I protein, which is produced by the human body after a heart attack. The purpose of this test is to obtain indications for cardiac infarction in patients who have suffered from chest pain in a recent period. In communication with Anvisa, Abbott Laboratories do Brasil Ltda reported that the value of Cut Off (parameter used to define whether or not there is a change in the patient's cardiac condition) normally used in Brazil is 0.3ng / mL, higher than 0 , 1ng / mL.
Reason
The analytical sensitivity of 0.01ng / ml of the architect stat troponin-i reagent diagnostic test may not be checked on all batches of the product. in this way, false-negative results can occur with results lower than 0.1ng / ml (functional test sensitivity) for all batches of this diagnostic test.
Action
According to information provided by the company Abbott Laboratories do Brasil Ltda, the necessary actions for this case by the users are the following: (a) For laboratories or doctors that use a band less than or equal to 0.1 ng / mL as cut -off, samples should be retested and / or serial blood collections negative, over time, should be evaluated before patients are classified as negative for heart attack; (b) Recent negative results less than 0.1 ng / mL should also be reassessed and the physicians who requested the examination request should be notified; (c) Laboratory reports with negative results less than 0.1 ng / mL should contain the observations of attention in the points of the previous items, alerting health professionals that small elevations of Troponin-I may be lost by the ARCHITECT STAT TROPONIN-I assay and that those negative results do not rule out the possibility of low troponin-I elevations; (d) If the health care professional has sent a consignment of ARCHITECT STAT Troponin-I to another laboratory, it shall communicate this information about the diagnostic kit to such laboratory. Abbott Laboratories of Brazil Ltda also informed Anvisa that it has already sent letters of communication reporting the problem to all customers who received the product.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Extra notes in the data
Source: NCAR
Reason
Device failure / feature before use - packing - operating instructions.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Please be aware that not all the test strips of the lots mentioned above have a filling time higher than expected. The blood glucose monitors used with these test strips are not affected. UPDATE OF INFORMATION: On January 6, 2011, the TechnoVigilance Unit held a meeting with Abbott Company where it provided further clarification on the deviation and the strategy of action that would be developed in Brazil, as well as in other countries that received the strips -test and that do not fit in the situations of risk observed in the analysis of the Company (time of exposure to high temperatures and term of validity of the product)
Reason
Abbott diabetes care has identified, during routine quality assurance monitoring, that lots of optium blood glucose test strips have shown longer than expected filling time. this fact may be dependent on the age of the strips and the storage (or exposure) at high temperatures (30 ° c) for a long period of time. when this occurs (ie the fill time is greater than five (5) seconds, as indicated in the test strips and attached video instruction), a false low reading may occur.
Action
The Abbott Diabetes Care risk assessment process evaluated the problem as being of Low Risk, in general, for patients. The risk assessment included data based on Mean Kinetic Temperature (MCT) and expiration date for Abbott products in the different regions. The analysis showed that the performance of these strips does not differ from the other strips under use under normal conditions. This indicates that the situation of filling time above that expected only occurs in the worst cases of continuous storage conditions, for extended periods of time. Customers with test strips that did not demonstrate a longer than expected period of filling may continue to use these strips. Customers who have test strips from the aforementioned lots and evidence the fill time above the expected time on their strips should contact the Abbott Call Center 0800 703 0128 and the affected box will be exchanged free of charge.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Abbott indicates that strips exposed to temperatures between 22 ° C and 30 ° C and / or extended storage times may be more susceptible to false result. It is possible to point out that up to the present time Abbott Diabetes Care Brazil had no reported complaints about falsely low blood glucose results, based on the reason for the American recall. Blood glucose monitors have not been affected and your users can continue to use their glucose meter normally. ANVISA follows this case. ###### SEE UPDATE ON ALERT 1044. #######
Reason
Affected test strips may provide falsely low blood glucose results, which may lead users to attempt to correct blood glucose unnecessarily and raise blood glucose levels due to a falsely low reading. the problem seems to be related to the application of the drop of blood in the test strip, requesting that it reapply blood more times than expected. this may occur regardless of the validity of the test strips, and / or if the test strips were stored at (or exposed to) high temperatures above 22 ° c and not exceed 30 ° c for an extended period of time.
Action
Customers who hold test strips for affected lots should not continue to use the product. Abbott Diabetes Care will replace these affected test strips at no cost. Abbott Diabetes Care of the United States initiated this recall following an internal routine quality analysis which indicated that blood glucose test strips from certain batches of Precision Xtra, Precision Xceed Pro, MediSense Optium, OptiumEZ and ReliOn Ultima products may require reapplication more than expected, which can cause false readings of blood glucose. PLEASE OBSERVE THE APPEARANCE CAREFULLY IN ANNEX.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Recall of abbott's glucose test stripsthe department of health (dh) has directed local supplier abbott laboratories limited to recall 359 lots of glucose test strips which may give falsely low blood glucose results today (december 23).
the recall followed assessment of a us food and drug administration (fda) alert, captured by dh's routine surveillance system, which involved the recall of 359 different lots of glucose test strips marketed by abbott diabetes care in the us under the following brand names:
* precision xceed pro;
* precision xtra;
* medisense optium;
* optium;
* optiumez; and
* relion ultima
the blood glucose monitoring systems are not affected by this recall.
more details of the recall are posted under fda news (medical devices) and the abbott diabetes care respectively:
http://www.Fda.Gov/newsevents/newsroom/
pressannouncements/ucm237900.Htm
http://www.Precisionoptiuminfo.Com/img/lot-numbers.Pdf
according to initial information from the local supplier, at least the following items and lot numbers in the list of test strips are available in hong kong:
medisense optium blood glucose electrodes
* lot 45001a137
* lot 45001a921
precision xceed pro blood glucose test strips
* lot 44cr5h
abbott's records revealed that some 6,000 boxes of the above lots are available in hong kong.
a spokesman for dh said although records showed that only three lots were shipped to hong kong, it was necessary to recall all 359 lots of products as some products might have been directly brought back to hong kong by consumers or purchased over the internet.
so far, the dh has not received any report of adverse events arising from the affected products.
members of the public should stop using any of the 359 lots of products and contact healthcare professionals if in doubt.
they may contact the company at hotline 2806 4488 daily from 9am to 5pm for recall arrangements.
hospitals, medical associations and nursing homes have been alerted. the department will closely monitor the recall. investigation continues.
thursday, december 23, 2010.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
In agreement with Afssaps, Roche Diagnostics France has recalled a batch of Accu-Chek Performa strips. The affected customers received the enclosed form (18/05/2011) (98 KB). A press release. giving more information on this recall is available on the Afssaps website.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Extra notes in the data
Source: FSCA
Reason
Device failure / feature before use - material / component.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Extra notes in the data
Action
Instrumentation Laboratory safety note for potassium determination sensors on the Premier 4000 GEM analyzer.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Fda class i recall: gem premier 4000 pak cartridges for use on the gem premier 4000 system
it has come to our attention that the u.S. food and drug administration (fda) has issued an class i recall to remind healthcare providers and patients that gem premier 4000 pak cartridges for use on the gem premier 4000 portable critical care system, which is manufactured by instrumentation laboratory company, may give inaccurate results.
potassium test results on the gem premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/l by as much as 2.0 mmol/l. use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death.
to avoid this, the manufacturer recommended customers to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.
according to the local supplier, hong kong is affected. the local supplier has contacted the affected customers for corrective actions
for details, please refer to the following link:
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm266113.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.
Extra notes in the data
The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro - glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope - Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
The registration holder of the medical device, Johnson & Johnson S.E. do.o. has in collaboration with the manufacturer LifeScanEurope - Division of Cilag GmbH International, Switzerland initiated a safety corrective measure recalling the product OneTouch®Pro from the market. The defective product will be replaced by an accurate one.
Hereby we inform all users to stop using the product OneTouch®Pro - glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro - glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
No adverse event report associated with the use of OneTouch®Pro - glycaemic self-management system has been received in Croatia by now.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland.
Extra notes in the data
Advice regarding a device removal. 3rd Party Publications
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.