# FDA recall Z-2938-2020

> **Qiagen Sciences LLC** · Class II · device recall initiated 2020-07-15.

## Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

## Reason for recall

There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.

## Distribution

US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.

## Key facts

- **Recall number:** Z-2938-2020
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-15
- **Report date:** 2020-09-16
- **Termination date:** 2021-03-22

- **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-2938-2020

## Citation

> AI Analytics. FDA recall Z-2938-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2938-2020. Source: US FDA. Licensed CC0.

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