# FDA recall Z-1877-2025

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2025-04-30.

## Product

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

## Reason for recall

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

## Distribution

International distribution in the country of Singapore.

## Key facts

- **Recall number:** Z-1877-2025
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-30
- **Report date:** 2025-06-04

- **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-1877-2025

## Citation

> AI Analytics. FDA recall Z-1877-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1877-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*