BEUDAMED
    FDA Enforcement Class II Ongoing

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    Recall: Z-1564-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1564-2022
    Event ID
    90596
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 20, 2022
    Classification Date
    August 23, 2022
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    Description

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    Reason

    There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

    Code Info

    Lot numbers distributed in the U.S.: Z012MK1MS, exp. 28-NOV-2022; Z012ML1MS, exp. 28-NOV-2022; Z012NB1MS, exp. 28-DEC-2022; Z013AL1MS, exp. 28-JAN-2023. UDI: 03573026139339.

    Distribution

    Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.

    Quantity

    1,301 kits