# FDA recall Z-2609-2025

> **Biofire Defense** · Class II · device recall initiated 2025-07-10.

## Product

FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.

## Reason for recall

FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.

## Distribution

US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.

## Key facts

- **Recall number:** Z-2609-2025
- **Recalling firm:** Biofire Defense
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-10
- **Report date:** 2025-10-01

- **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-2609-2025

## Citation

> AI Analytics. FDA recall Z-2609-2025. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-2609-2025. Source: US FDA. Licensed CC0.

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