# FDA recall Z-1903-2021

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2021-05-10.

## Product

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

## Reason for recall

Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

## Distribution

US nationwide distribution

## Key facts

- **Recall number:** Z-1903-2021
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-10
- **Report date:** 2021-06-30
- **Termination date:** 2022-12-15

- **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-1903-2021

## Citation

> AI Analytics. FDA recall Z-1903-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1903-2021. Source: US FDA. Licensed CC0.

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