# FDA recall Z-2245-2021

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2021-07-20.

## Product

FilmArray Blood Culture Identification (BCID) Panel    Product Pouch Label:  FilmArray BCID Panel    Part No: RFIT-ASY-0126  Part No: RFIT-ASY-0127

## Reason for recall

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

## Distribution

U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI.    O.U.S.: None

## Key facts

- **Recall number:** Z-2245-2021
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-20
- **Report date:** 2021-08-18
- **Termination date:** 2022-12-16

- **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-2245-2021

## Citation

> AI Analytics. FDA recall Z-2245-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2245-2021. Source: US FDA. Licensed CC0.

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