NxTAG Respiratory Pathogen Panel +SARS-CoV-2 — Class II medical device recall Z-0043-2025
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-0043-2025 |
|---|---|
| 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 | 613 |
| Reason classes | microbial contamination |
| Lot numbers | IK056C-0033, IK056C-0034, IK056C-0035, IK056C-0036, IK056C-0037, IK056C-0038, IK056C-0039 |
| Model numbers | I056C0468 |
Product
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
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-0043-2025. 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.