Known Identifiers & Locations
FEI Numbers
3002777243
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0042-2025 |
NxTAG Respiratory Pathogen Panel, REF: I051C0447
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.
|
2024-09-05 |
Open, Classified
|
View Details
|
| Z-0043-2025 |
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.
|
2024-09-05 |
Open, Classified
|
View Details
|
Profile Disclaimer
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