BEUDAMED
    FDA Enforcement Class III Ongoing

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    Recall: Z-2093-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2093-2023
    Event ID
    92490
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuMoDx Molecular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    May 15, 2023
    Classification Date
    July 5, 2023
    Address
    1250 Eisenhower Pl, N/A, Ann Arbor, MI, 48108-3281, United States

    Description

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    Reason

    Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

    Code Info

    GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023

    Distribution

    US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.

    Quantity

    1,086 test strips