BEUDAMED
    FDA Recall Terminated

    NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

    Recall: Z-2740-2011 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-2740-2011
    Event Number
    58792
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2011
    Posted
    July 6, 2011
    Terminated
    October 6, 2011
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

    Reason

    The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples.

    Action

    BioMerieux Vitek, Inc. sent an "Urgent Product Correction Notice" letter on/about May 10, 2011. The letter included; a description of the product, problem, possible impact to the patient and recommendations. Recommendations included instructing customers to discontinue the use of the kit for the detection of Enterovirus 68 and Rhinovirus 87 serotypes and noted the corrected IFU will be available the first week of April 2011. An Acknowledgement form was attached to be returned via fax. For additional questions please contact your local BioMerieux Clinical Customer representative at (800) 682-2666, option 3, option 2.

    Distribution

    (USA) Nationwide distribution including the states of MD, MI, MN, MT, NY and PA

    Quantity

    42 kits