Luminex Molecular Diagnostics Inc: Device Recall

Recall #Z-0043-2025 · 09/05/2024

Class II: Risk

Recall Details

Recall Number: Z-0043-2025
Classification: Class II
Product Type: Device
Recalling Firm: Luminex Molecular Diagnostics Inc
Status: Ongoing
Date Initiated: 09/05/2024
Location: Toronto, Canada
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 613

Reason for Recall

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.

Product Description

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

Distribution Pattern

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.

Other Recalls by Luminex Molecular Diagnostics Inc

Class II: Risk 09/05/2024

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.

View all recalls by Luminex Molecular Diagnostics Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.