In Vitro Diagnostic — Class II medical device recall Z-1251-2023
Ongoing recall by BioFire Diagnostics, LLC, reported 2023-03-22, distributed nationwide. Due to temperature excursions with products (products being stored outside of the required temperature specifi
| Recall number | Z-1251-2023 |
|---|---|
| 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 | 2023-02-01 |
| Classified | 2023-03-15 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 2 kits |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 00815381020338 |
| Lot numbers | 1766022 |
| Model numbers | RFIT-ASY-0147 |
Product
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Reason for recall
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
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-1251-2023. 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.