FDA Device recall Z-0042-2025
NxTAG Respiratory Pathogen Panel, REF: I051C0447
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of NxTAG Respiratory Pathogen Panel, REF: I051C0447 by Luminex Molecular Diagnostics, citing respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified pred….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0042-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-05 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Luminex Molecular Diagnostics |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024, IK051C-0182/ 9/30/2024, IK051C-0185/ 9/30/2024, IK051C-…UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024, IK051C-0182/ 9/30/2024, IK051C-0185/ 9/30/2024, IK051C-0186/ 9/30/2024, IK051C-0187/ 10/31/2024, IK051C-0188/ 10/31/2024, IK051C-0189/ 10/31/2024, IK051C-0190/ 10/31/2024, IK051C-0191/ 10/31/2024, IK051C-0192/ 10/31/2024, IK051C-0193/ 10/31/2024, IK051C-0194/ 10/31/2024, IK051C-0195/ 10/31/2024, IK051C-0196/ 11/30/2024, IK051C-0197/ 12/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2025%22
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