# FDA recall Z-2682-2024

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2024-06-10.

## Product

BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

## Reason for recall

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

## Distribution

Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.

## Key facts

- **Recall number:** Z-2682-2024
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-10
- **Report date:** 2024-08-28

- **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-2682-2024

## Citation

> AI Analytics. FDA recall Z-2682-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2682-2024. Source: US FDA. Licensed CC0.

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