# FDA recall Z-1133-2019

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2019-03-07.

## 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.

## Distribution

MA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM

## Key facts

- **Recall number:** Z-1133-2019
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-04-24
- **Termination date:** 2022-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2019

## Citation

> AI Analytics. FDA recall Z-1133-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1133-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*