BEUDAMED
    FDA Enforcement Class II Terminated

    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).

    Recall: Z-0732-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0732-2019
    Event ID
    81787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2019
    Initiation Date
    December 17, 2018
    Classification Date
    January 14, 2019
    Termination Date
    April 30, 2020
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States

    Description

    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).

    Reason

    An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.

    Code Info

    Lot Numbers: 602096K089, 602096K090, 602096K091

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.

    Quantity

    184