BEUDAMED
    FDA Enforcement Class II 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 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0987-2013
    Event ID
    63946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    December 18, 2012
    Classification Date
    March 25, 2013
    Termination Date
    July 31, 2013
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313, United States

    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

    Code Info

    All shipped out to this date

    Distribution

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

    Quantity

    12