# FDA recall Z-1448-2020

> **Biofire Defense** · Class III · device recall initiated 2019-08-20.

## Product

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

## Reason for recall

The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

## Distribution

US: UT, MD, GA, CO, OH, TX,  OUS: None

## Key facts

- **Recall number:** Z-1448-2020
- **Recalling firm:** Biofire Defense
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-20
- **Report date:** 2020-03-11
- **Termination date:** 2020-10-30

- **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-1448-2020

## Citation

> AI Analytics. FDA recall Z-1448-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1448-2020. Source: US FDA. Licensed CC0.

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