Events

Recall of 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
    53649
  • Event Risk Class
    Class 2
  • Event Number
    Z-0867-2010
  • Event Initiated Date
    2009-10-12
  • Event Date Posted
    2010-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86262
  • 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
    Product update kit cd rom will not upload. as a result, the device cannot be run.
  • Action
    The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.

Device

Variant II Turbo Hemoglobin A1C Program
  • Model / Serial
    Lot No. 70291520.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Hong Kong, and New Zealand.
  • Product Description
    Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. || Intended Use: 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