Events

Recall of BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0

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
    50174
  • Event Risk Class
    Class 2
  • Event Number
    Z-1041-2009
  • Event Initiated Date
    2008-10-17
  • Event Date Posted
    2009-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74902
  • 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
    Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
  • Action
    An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.

Device

BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0
  • Model / Serial
    version 4.0 software
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA || Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
  • 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