FilmArray BCID Panel — Class II medical device recall Z-1513-2018
Terminated recall by BioFire Diagnostics, LLC, reported 2018-05-02, distributed nationwide. There is an increased risk of false positive Proteus results when the product is used with specific types of B
| Recall number | Z-1513-2018 |
|---|---|
| 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 | 2018-03-14 |
| Classified | 2018-04-25 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2018-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GR, GT, HK, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MX, MY, NI, NL, PA, PE, PH, PL, PT, QA, RO, SA, SE, SG, SI, TR, UY, ZA |
| UPC / GTIN / UDI-DI | 00815381020086, 00815381020093 |
| Model numbers | 442020, 442021, 442022, 442023, 442191, 442192, 442193, 442194, 442260, 442265, RFIT-ASY-0126 |
Product
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Reason for recall
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
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-1513-2018. 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.