Events

Recall of Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System

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
    54746
  • Event Risk Class
    Class 2
  • Event Number
    Z-1259-2011
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2011-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89093
  • 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, glycosylated hemoglobin - Product Code LCP
  • Reason
    The results from the blood device had the occurrence of some ramping baselines on their chromatograms. the ramping baseline can affect quantitation of the blood results.
  • Action
    The firm, Bio-Rad Laboratories, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.

Device

Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System
  • Model / Serial
    Catalog No. 270-2716 Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.
  • Product Description
    Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide || Intended use: Measurement of Hemoglobin A1c in human whole blood.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA