BEUDAMED
    FDA Enforcement Class I Terminated

    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

    Recall: Z-1930-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1930-2012
    Event ID
    61927
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    May 22, 2012
    Classification Date
    July 6, 2012
    Termination Date
    October 18, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997, United States

    Description

    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.

    Reason

    Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

    Code Info

    Phase 1: K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B, W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B. Phase 2: W50015B, W50029B, and W50788B.

    Distribution

    Nationwide Distribution

    Quantity

    5,013 kits