BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1259-2011 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-1259-2011
    Event Number
    54746
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 19, 2010
    Posted
    February 15, 2011
    Terminated
    March 3, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    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.

    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.

    Distribution

    Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.

    Quantity

    27