BEUDAMED
    FDA Recall Terminated

    Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.

    Recall: Z-0065-2008 · Initiated September 5, 2007

    Recall

    Recall Number
    Z-0065-2008
    Event Number
    44881
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 5, 2007
    Posted
    October 31, 2007
    Terminated
    November 15, 2007
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.

    Reason

    Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.

    Action

    On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.

    Distribution

    Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.

    Quantity

    46