Events

Recall of VARIANT II Link Hemoglobin A1c Program Reorder Pack

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
    60230
  • Event Risk Class
    Class 3
  • Event Number
    Z-0399-2012
  • Event Initiated Date
    2011-10-25
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104832
  • 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
    Calibrator, hemoglobin and hematocrit measurement - Product Code KRZ
  • Reason
    It was discovered that the variant ii turbo link calibrator values card contains incorrect values for ifcc units. the numbers are missing a decimal point.
  • Action
    Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114.

Device

VARIANT II Link Hemoglobin A1c Program Reorder Pack
  • Model / Serial
    Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
  • Product Description
    VARIANT II Link Hemoglobin A1c Program Reorder Pack, || 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. || Contents: || Elution Buffer A , 1 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set || CD ROM - 1 || Calibrator/Diluent Set || Whole Blood Primer, 6 x 1 mL || Sample vials, 2 x 100 || Instruction Manual || Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).
  • 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