# FDA recall Z-1504-2025

> **Qiagen Sciences LLC** · Class II · device recall initiated 2025-03-12.

## Product

Brand Name: QIAstat-Dx  Product Name: QIAstat-Dx Respiratory Panel Plus  Reference Number (REF): 691224  Software Version: n/a  Component: n/a

## Reason for recall

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

## Distribution

US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.

## Key facts

- **Recall number:** Z-1504-2025
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-12
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2025

## Citation

> AI Analytics. FDA recall Z-1504-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1504-2025. Source: US FDA. Licensed CC0.

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