# FDA recall Z-1683-2023

> **Qiagen Sciences LLC** · Class II · device recall initiated 2023-04-28.

## Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

## Reason for recall

Faulty cartridges in the lot could result in false test results.

## Distribution

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

## Key facts

- **Recall number:** Z-1683-2023
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-28
- **Report date:** 2023-06-14

- **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-1683-2023

## Citation

> AI Analytics. FDA recall Z-1683-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1683-2023. Source: US FDA. Licensed CC0.

---

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