BEUDAMED
    FDA Enforcement Class II Terminated

    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.

    Recall: Z-2267-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2267-2013
    Event ID
    65883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microgenics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    July 23, 2013
    Classification Date
    September 23, 2013
    Termination Date
    December 2, 2013
    Address
    46360 Fremont Blvd, N/A, Fremont, CA, 94538-6406, United States

    Description

    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.

    Reason

    Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.

    Code Info

    Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.

    Distribution

    US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL

    Quantity

    1473 units in distribution.