# FDA recall Z-2440-2023

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2023-05-08.

## Product

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

## Reason for recall

Due to manufacturing issue, panels may result  in false negative results.

## Distribution

US: CA    	CO    	CT    	FL    	GA    	IA    	IL    	IN    	LA    	MA    	MI    	MO    	MT    	NC    	NE    	NJ    	NM    	NY    	OH    	OK    	PA    	TN    	UT    	WV      OUS: Canada, India, Japan, Singapore, Colombia

## Key facts

- **Recall number:** Z-2440-2023
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-08
- **Report date:** 2023-08-30

- **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-2440-2023

## Citation

> AI Analytics. FDA recall Z-2440-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2440-2023. Source: US FDA. Licensed CC0.

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