Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 — Class II medical device recall Z-2081-2026
Ongoing recall by BioFire Diagnostics, LLC, reported 2026-05-13, distributed nationwide. Respiratory/sore throat panel test may result in false negative results and control failures.
| Recall number | Z-2081-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2026-04-01 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,400 pouches |
| UPC / GTIN / UDI-DI | 00815381020390 |
| Lot numbers | 2215125 |
| Model numbers | 423485 |
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason for recall
Respiratory/sore throat panel test may result in false negative results and control failures.
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-2081-2026. 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.