BEUDAMED
    FDA Recall Open, Classified

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    Recall: Z-0043-2025 · Initiated September 5, 2024

    Recall

    Recall Number
    Z-0043-2025
    Event Number
    95377
    Firm
    Luminex Molecular Diagnostics Inc
    FEI Number
    3002777243
    Product Code
    QLT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 5, 2024
    Posted
    October 9, 2024
    Address
    439 University Ave, Toronto Canada Suite 900

    Description

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    Reason

    Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

    Action

    On 9/5/24, recall notices were sent to customers and distributors were were asked to do the following: 1. Two options are available to overcome the sporadic potential risk of the hMPV false positive result: A. Continue to use the product as per its instruction for use: in case of a positive result for hMPV, consider performing confirmatory testing with another method before reporting the hMPV result, if medically indicated. B. Exclude the hMPV from the reporting by removing this target from the assay analysis, as explained in the package insert under the chapter "Define Test Panels in SYNCT Software". See Document No. and Revision/Page reference: MLD-051-KPI-001 Rev H/Page 17, MLD-056-KPI-001 Rev. E/Page 18. 2. Notify others within your network that may have remaining inventory of those kits. 3. If you are a distributor, provide a copy of this letter to customers or organizations who received impacted lots. 4. Complete and return the response form via email to [email protected] 5. For complaints, questions, or concerns, please contact Technical Support using the contact information: 1-877-785-2323 (U.S. and Canada). +1-512-381-4397 (Outside U.S. and Canada). 1-512-219-5114 (Fax). [email protected] www.diasorin.com

    Distribution

    U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.

    Quantity

    613