FilmArray Blood Culture Identification — Class II medical device recall Z-0296-2019
Terminated recall by BioFire Diagnostics, LLC, reported 2018-11-07, distributed nationwide. Increased risk of false positive results for Proteus when the product is used with a specific blood culture bo
| Recall number | Z-0296-2019 |
|---|---|
| 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 | 2018-09-05 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2021-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, KW, LB, MY, NI, OM, PA, PE, PH, PY, QA, RO, SA, SI, UY, VN |
| Quantity | 18,038 |
| UPC / GTIN / UDI-DI | 00815381020086, 00815381020093 |
Product
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,
Reason for recall
Increased risk of false positive results for Proteus when the product is used with a specific 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-0296-2019. 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.