Events

Recall of Device Recall VARIANT II TURBO Hemoglobin A1c Program

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
    56387
  • Event Risk Class
    Class 3
  • Event Number
    Z-1342-2011
  • Event Initiated Date
    2010-03-24
  • Event Date Posted
    2011-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93350
  • 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
    Glycosylated Hemoglobin Assay - Product Code LCP
  • Reason
    The firm received customer complaints associated with the update kit cd-rom not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
  • Action
    Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.

Device

Device Recall VARIANT II TURBO Hemoglobin A1c Program
  • Model / Serial
    Lot Numbers: 70200185.   Lot Nos.: 70200185, AA00190
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Italy.
  • Product Description
    Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. || Intended for the percent 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 Dr, Hercules CA 94547-1803
  • Source
    USFDA