BEUDAMED
    FDA Recall Terminated

    BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.

    Recall: Z-1158-2008 · Initiated November 13, 2007

    Recall

    Recall Number
    Z-1158-2008
    Event Number
    45875
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LSE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 13, 2007
    Posted
    June 11, 2008
    Terminated
    May 23, 2011
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.

    Reason

    False negative results due to reagent packs exhibiting low signal.

    Action

    On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.

    Distribution

    Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

    Quantity

    996 kits