BEUDAMED
    FDA Recall 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 · Initiated December 17, 2018

    Recall

    Recall Number
    Z-0732-2019
    Event Number
    81787
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    MDU
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 17, 2018
    Terminated
    April 30, 2020
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    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.

    Action

    Urgent: Voluntary Medical Device Recall notification letters dated 12/17/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. The letters instructed customers to review inventory for affected lots, forward the letter to any customers, contact the firm replacement product, complete the response form. For questions contact Meridian's Technical Service Department by telephone at 800-343-3858 or 513-271-3700 or by facsimile 513-272-5432.

    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