BEUDAMED
    FDA Recall Terminated

    Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.

    Recall: Z-0376-2007 · Initiated November 17, 2006

    Recall

    Recall Number
    Z-0376-2007
    Event Number
    37097
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2006
    Posted
    January 25, 2007
    Terminated
    November 28, 2007
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.

    Reason

    The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

    Action

    The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.

    Distribution

    Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.

    Quantity

    900 kits, 43 sets distributed.