# FDA recall Z-1944-2021

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2021-04-16.

## Product

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

## Reason for recall

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

## Distribution

U.S. Nationwide distribution in the states of MN and OK.    O.U.S.: None

## Key facts

- **Recall number:** Z-1944-2021
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-16
- **Report date:** 2021-06-30
- **Termination date:** 2024-04-02

- **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-1944-2021

## Citation

> AI Analytics. FDA recall Z-1944-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1944-2021. Source: US FDA. Licensed CC0.

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