Events

Recall of D10 Hemoglobin A1c Program Reorder Pack: 400 tests

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59868
  • Event Risk Class
    Class 3
  • Event Number
    Z-0017-2012
  • Event Initiated Date
    2011-09-12
  • Event Date Posted
    2011-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103895
  • Notes / Alerts
    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
    Assay, glycoslylated hemoglobin - Product Code LCP
  • Reason
    A previous recall related to reports of calibration failure and late retention times using elution buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
  • Action
    Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product. Customers were asked to please translate (if necessary) the attached "Customer Medical Device Correction Response Form," customers should add their local contact information and distribute to all affected customers in their region by mail or fax. Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter. Complete the "SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD. Customers would be issued credits for the affected products based on their request. For questions call (510) 741-3954.

Device

D10 Hemoglobin A1c Program Reorder Pack: 400 tests
  • Model / Serial
    Model number: 220-0101; Lot number/Expiry: 20010946. 11/30/12; 20011075, 11/30/12;  Contain Buffer lot AA10888/AA10889, expiry 3/31/13;  20011077, 11/30/12; 20011079, 11/30/12; 20011081, 11/30/12. Contain Buffer lot AA10440/AA10441, expiry 2/28/13.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
  • Product Description
    D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; || For the determination of Hemoglobin A1c in human whole blood. IVD || Contents: || 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer || 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer || 3. Wash/Diluent 1 x 1600 mL Deionized water || 4. Analytical cartridge - 1 cation exchange cartridge || 5. Floppy Diskette 1-program parameters || 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. || 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. || 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid || 9 Thermal paper - 1 roll || 10. Instruction manual || Made in United States || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA