# FDA recall Z-2246-2023

> **Qiagen GmbH** · Class II · device recall initiated 2023-05-19.

## Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel  (V1 and V2, CE IVD, not US IVD, not sold in the US.)   Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection   REF: 691214

## Reason for recall

Identified a decreased performance reliability rate,  Run abortions could cause delayed diagnosis since sample testing would have to be repeated

## Distribution

DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign:  DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA

## Key facts

- **Recall number:** Z-2246-2023
- **Recalling firm:** Qiagen GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-19
- **Report date:** 2023-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hilden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2246-2023

## Citation

> AI Analytics. FDA recall Z-2246-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2246-2023. Source: US FDA. Licensed CC0.

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