# FDA recall Z-1451-2020

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2019-08-08.

## Product

FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

## Reason for recall

Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.

## Distribution

US: KY, IL, NJ, MS

## Key facts

- **Recall number:** Z-1451-2020
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-08
- **Report date:** 2020-03-18
- **Termination date:** 2022-04-12

- **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-1451-2020

## Citation

> AI Analytics. FDA recall Z-1451-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1451-2020. Source: US FDA. Licensed CC0.

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