Device product
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0043-2025
Product summary
- Event
- Event 95377
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 613
- Official record key
device-enforcement:Z-0043-2025
Official wording
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.
Code information: 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
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.
Derived failure modes
-
Unknown
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.