FDA Device recall Z-0043-2025
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
- 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 +SARS-CoV-2, REF: I056C0468 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-0043-2025 |
| 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 +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.
Identifiers
| code_info | Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK05…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 |
|---|
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-0043-2025%22
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