BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 24, 2023

    Recall

    Recall Number
    Z-2255-2023
    Event Number
    92615
    Firm
    NeuMoDx Molecular Inc
    FEI Number
    3010729479
    Product Code
    PPM
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    May 24, 2023
    Posted
    July 28, 2023
    Address
    1250 Eisenhower Pl, Ann Arbor, MI, 48108-3281

    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

    Action

    Qiagen issued customers "Urgent: Medical Device Correction" Letter via email on 5/24/23. Letter states reason for recall, health risk and action to take: If you have remaining stock of cartridges LOT 117514, 117524 or 117528, REF 100100, do not use it. Please contact QIAGEN Technical Service for a free-of-charge replacement. Dispose of the product LOT 117514, 117254, and 117528 in accordance with your national and local safety and environmental regulations. If you have already used NeuMoDx Cartridges from this LOT, please review all results obtained with the laboratory director and assess whether retesting is required. Review this notice with your laboratory/medical director. Important: Forward this information to all individuals and departments within your organization using the above listed cartridges. If you are not the end user, please forward this notice to the product end user. Complete Acknowledgement of Receipt attached to this letter by as soon as possible. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: www.qiagen.com/QIAGEN-Subsidiaries.

    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