BEUDAMED
    FDA Recall Terminated

    AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20;

    Recall: Z-1046-2009 · Initiated January 19, 2009

    Recall

    Recall Number
    Z-1046-2009
    Event Number
    50816
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 19, 2009
    Posted
    April 15, 2009
    Terminated
    September 11, 2010
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20;

    Reason

    Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

    Action

    Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and discard any reagent packs that do not open properly. If a probe crash is observed prior to testing samples again, a probe crash recovery must be performed following the procedure in the Operations Manual. A copy of the communication needs to be provided to any laboratory that you may have forwarded affected lots to. Users were requested to return a customer reply letter acknowledging receipt and understanding of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.

    Distribution

    Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.

    Quantity

    1,540 kits