# FDA recall Z-2067-2026

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2026-04-22.

## Product

BioFire Joint Infection (JI) Panel  REF: RFIT-ASY-0138, 30 test Kit.

## Reason for recall

Contamination to in-vitro diagnostic test   may result in false positives.

## Distribution

Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, 	Dominican Republic, Serbia.

## Key facts

- **Recall number:** Z-2067-2026
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-22
- **Report date:** 2026-05-13

- **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-2067-2026

## Citation

> AI Analytics. FDA recall Z-2067-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2067-2026. Source: US FDA. Licensed CC0.

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