BEUDAMED
    FDA Recall Terminated

    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

    Recall: Z-0327-06 · Initiated December 15, 2005

    Recall

    Recall Number
    Z-0327-06
    Event Number
    34238
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2005
    Posted
    January 6, 2006
    Terminated
    August 7, 2007
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

    Reason

    Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.

    Action

    Letters sent overnight mail on 12/15/2005. Customers instructed to discontinue use and discard remaining inventory. In a separate Q&A sheet, Ortho recommends that previously reported results be reviewed.

    Distribution

    Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.

    Quantity

    436 kits