NxTAG Respiratory Pathogen Panel — Class II medical device recall Z-0042-2025
Ongoing recall by Luminex Molecular Diagnostics Inc, reported 2024-10-16, distributed nationwide. Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-speci
| Recall number | Z-0042-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Molecular Diagnostics Inc, Toronto, Canada |
| Recall initiated | 2024-09-05 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,375 |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00840487100417 |
| Lot numbers | IK051C-0181, IK051C-0182, IK051C-0185, IK051C-0186, IK051C-0187, IK051C-0188, IK051C-0189, IK051C-0190, IK051C-0191, IK051C-0192, IK051C-0193, IK051C-0194, IK051C-0195, IK051C-0196, IK051C-0197 |
| Model numbers | I051C0447 |
Product
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0042-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.