BioFire BCID2 Panel — Class II medical device recall Z-1903-2021
Terminated recall by BioFire Diagnostics, LLC, reported 2021-06-30, distributed nationwide. Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufa
| Recall number | Z-1903-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2021-05-10 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2022-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 870 kits |
| UPC / GTIN / UDI-DI | 00815381020338 |
| Lot numbers | 11YA20, 2039020 |
| Model numbers | RFIT-ASY-0147 |
Product
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Reason for recall
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
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-1903-2021. 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.