# FDA recall Z-0703-2024

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2023-11-27.

## Product

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.

## Reason for recall

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

## Distribution

US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD

## Key facts

- **Recall number:** Z-0703-2024
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-27
- **Report date:** 2024-01-17

- **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-0703-2024

## Citation

> AI Analytics. FDA recall Z-0703-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0703-2024. Source: US FDA. Licensed CC0.

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