BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1041-2009 · Initiated October 17, 2008

    Recall

    Recall Number
    Z-1041-2009
    Event Number
    50174
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 17, 2008
    Posted
    March 24, 2009
    Terminated
    November 12, 2010
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    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.

    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.

    Distribution

    Worldwide Distribution

    Quantity

    92 units