FilmArray Blood Culture Identification — Class II medical device recall Z-2245-2021
Terminated recall by BioFire Diagnostics, LLC, reported 2021-08-18, distributed nationwide. Due to product complaints received for false negative results (dropouts) with blood culture identification pan
| Recall number | Z-2245-2021 |
|---|---|
| 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 | 2021-07-20 |
| Classified | 2021-08-11 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2022-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 29 kits |
| UPC / GTIN / UDI-DI | 00815381020086, 00815381020093 |
| Lot numbers | 003, 0868221, 194Z21 |
| Model numbers | RFIT-ASY-0126, RFIT-ASY-0127 |
Product
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Reason for recall
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
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-2245-2021. 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.