# FDA recall Z-0941-2021

> **Qiagen Sciences LLC** · Class II · device recall initiated 2021-01-15.

## Product

SARS-CoV-2 Antigen Test

## Reason for recall

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

## Distribution

Domestic: AZ, CA, DC, CO,FL,HI, IL,  KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY

## Key facts

- **Recall number:** Z-0941-2021
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-15
- **Report date:** 2021-02-10
- **Termination date:** 2022-07-11

- **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-0941-2021

## Citation

> AI Analytics. FDA recall Z-0941-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0941-2021. Source: US FDA. Licensed CC0.

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