FilmArray BCID Panel — Class II medical device recall Z-2296-2020
Terminated recall by BioFire Diagnostics, LLC, reported 2020-06-17, distributed nationwide. There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identific
| Recall number | Z-2296-2020 |
|---|---|
| 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 | 2020-01-22 |
| Classified | 2020-06-08 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CL, CR, CZ, DE, DO, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IL, IN, IQ, IT, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NI, NL, OM, PA, PE, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VN, ZA |
| Quantity | 5,020 kits |
| UPC / GTIN / UDI-DI | 00815381020093 |
Product
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Reason for recall
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
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-2296-2020. 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.