BEUDAMED
    FDA Enforcement Class II Terminated

    NucliSENS¿ Magnetic Extraction Reagents

    Recall: Z-0218-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0218-2019
    Event ID
    81067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    September 17, 2018
    Classification Date
    October 23, 2018
    Termination Date
    May 18, 2020
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    NucliSENS¿ Magnetic Extraction Reagents

    Reason

    Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

    Code Info

    Reference # 200293, Lot # 17121501, Expiration date 11/28/2018

    Distribution

    Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

    Quantity

    42 units