BEUDAMED
    FDA Enforcement Class II Ongoing

    NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100

    Recall: Z-2255-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2255-2023
    Event ID
    92615
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuMoDx Molecular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 9, 2023
    Initiation Date
    May 24, 2023
    Classification Date
    July 28, 2023
    Address
    1250 Eisenhower Pl, N/A, Ann Arbor, MI, 48108-3281, United States

    Description

    NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100

    Reason

    Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results

    Code Info

    GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528

    Distribution

    US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE

    Quantity

    20,016 cartridges