# FDA recall Z-0455-2022

> **Qiagen Sciences LLC** · Class II · device recall initiated 2021-11-08.

## Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

## Reason for recall

The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

## Distribution

Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.

## Key facts

- **Recall number:** Z-0455-2022
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-08
- **Report date:** 2022-01-12
- **Termination date:** 2023-03-29

- **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-0455-2022

## Citation

> AI Analytics. FDA recall Z-0455-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0455-2022. Source: US FDA. Licensed CC0.

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