# FDA recall Z-2215-2023

> **Qiagen GmbH** · Class II · device recall initiated 2023-05-09.

## Product

QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1,  Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella  pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae  REF 691223

## Reason for recall

If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported

## Distribution

AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA

## Key facts

- **Recall number:** Z-2215-2023
- **Recalling firm:** Qiagen GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-09
- **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-2215-2023

## Citation

> AI Analytics. FDA recall Z-2215-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2215-2023. Source: US FDA. Licensed CC0.

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