FDAFDA · Food and drugs·Recall number Z-0043-2025
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Published October 16, 2024 · Recall initiated: September 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Luminex Molecular Diagnostics Inc
- Distributor
- 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.
- Lot
- Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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