BEUDAMED
    FDA Recall Terminated

    Platelia Aspergillus EIA

    Recall: Z-0348-04 · Initiated November 6, 2003

    Recall

    Recall Number
    Z-0348-04
    Event Number
    28013
    Firm
    Bio Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    NOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 6, 2003
    Posted
    January 14, 2004
    Terminated
    January 27, 2004
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    Description

    Platelia Aspergillus EIA

    Reason

    Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.

    Action

    Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.

    Distribution

    The firm distributed to hospitals and diagnostic laboratories nationwide.

    Quantity

    147 kits