BEUDAMED
    FDA Recall Terminated

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    Recall: Z-2398-2012 · Initiated July 27, 2012

    Recall

    Recall Number
    Z-2398-2012
    Event Number
    62850
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 27, 2012
    Posted
    September 17, 2012
    Terminated
    December 14, 2012
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    Reason

    Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

    Action

    The firm, Bio-Rad Laboratories, Inc., sent an "Important Product Information Bio-Rad MONOLISA Anti-HBs EIA Catalog #25220", letter dated 27 July 2012, to their domestic consignees/customers via FedEx. The International subsidiaries will be notified by e-mail. The consignees/customers were informed of the important storage and handling information regarding the MONOLISA Anti-HBs EIA Conjugate Diluent component . The consignees/customers were instructed to follow the storage and handling instructions as stated in the Package Insert, and compare their laboratories practices to the storage and handling instructions stated by Bio-Rad. Customers who have questions can call Bio Rad Technical Support at 1-800-224-6723, option 2, then option 3.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.

    Quantity

    7,400 (approximately)- All lots since distribution date May 9, 2007