BEUDAMED
    FDA Recall Terminated

    VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.

    Recall: Z-1902-2010 · Initiated January 22, 2009

    Recall

    Recall Number
    Z-1902-2010
    Event Number
    51498
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 22, 2009
    Posted
    June 25, 2010
    Terminated
    March 22, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.

    Reason

    Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.

    Action

    Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.

    Distribution

    Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.