BEUDAMED
    FDA Recall Terminated

    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

    Recall: Z-1978-2021 · Initiated May 4, 2021

    Recall

    Recall Number
    Z-1978-2021
    Event Number
    88099
    Firm
    NeuMoDx Molecular Inc
    FEI Number
    3010729479
    Product Code
    QJR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 4, 2021
    Terminated
    June 21, 2022
    Address
    1250 Eisenhower Pl, Ann Arbor, MI, 48108-3281

    Description

    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

    Reason

    There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

    Action

    URGENT MEDICAL DEVICE CORRECTION notification letters dated 5/4/21 were sent to customers. Actions Required by Customers 1. IMMEDIATELY discontinue use of the product and discard remaining inventory in accordance with your national and local safety and environmental regulations. Please contact QIAGEN Technical Service for a free-of-charge replacement of scrapped inventory. 2. Share this Medical Device Correction Notice with all users of the NeuMoDxTM Cartridges in your facility to ensure they are aware of this notice. 3. If you have already used NeuMoDxTM Cartridges from any of these lots in combination with the NeuMoDxTM SARS-CoV-2 Assay or the NeuMoDx Flu-A-B/RSV/SARS-CoV-2 Assay, please review all SARS-CoV-2 positive results to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. Note: results for targets other than SARS-CoV-2 are not impacted by this medical device correction. 4. Complete the attached response form and return to [email protected] to confirm receipt of this notification. We sincerely apologize for any inconvenience this may have caused and thank you in advance for your patience and cooperation. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected]

    Distribution

    Worldwide distribution.

    Quantity

    620 cases (29,760 cartridges total)