FilmArray BCID Panel — Class II medical device recall Z-1133-2019
Terminated recall by BioFire Diagnostics, LLC, reported 2019-04-24, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture ide
| Recall number | Z-1133-2019 |
|---|---|
| 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 | 2019-03-07 |
| Classified | 2019-04-12 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2022-08-24 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 20,350 |
| Lot numbers | 4052458, 4052459, 4052471, 4052472, 4052503, 4052504, 4052546, 4052547, 4052564, 4052565, 4052598, 4052599, 405261, 4052617, 4052639, 4052640, 4052704, 4052705, 4052718, 4052735, 4052799, 4052800, 4052815, 4052816, 4052872, 410851/4052663, 410852/4052871, 410853/4052717 |
| Model numbers | PLUS/410851, RFIT-ASY-0126, RFIT-ASY-0127 |
Product
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, 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 Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain 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-1133-2019. 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.