BEUDAMED
    FDA Recall Terminated

    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

    Recall: Z-0987-2013 · Initiated December 18, 2012

    Recall

    Recall Number
    Z-0987-2013
    Event Number
    63946
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    December 18, 2012
    Posted
    March 25, 2013
    Terminated
    July 31, 2013
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

    Reason

    Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR

    Action

    The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.

    Distribution

    Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.

    Quantity

    12