BioFire Joint Infection — Class II medical device recall Z-2067-2026
Ongoing recall by BioFire Diagnostics, LLC, reported 2026-05-13, distributed nationwide. Contamination to in-vitro diagnostic test may result in false positives.
| Recall number | Z-2067-2026 |
|---|---|
| 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 | 2026-04-22 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DO, EG, ES, FI, FR, GB, IN, IT, LB, MA, NL, PL, RO, RS, SI |
| UPC / GTIN / UDI-DI | 00815381020192 |
| Lot numbers | 0878825/DI |
| Model numbers | RFIT-ASY-0138 |
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Reason for recall
Contamination to in-vitro diagnostic test may result in 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-2067-2026. 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.