QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the… — Class II medical device recall Z-2215-2023
Ongoing recall by Qiagen GmbH, reported 2023-08-02, distributed in AL, AR, CA, DC, FL, GA, ID, KS…. If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY0
| Recall number | Z-2215-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen GmbH, Hilden, N/A, Germany |
| Recall initiated | 2023-05-09 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY, PA, SC, TX, VA |
| Quantity | 368 kits |
| UPC / GTIN / UDI-DI | 14053228038846 |
| Lot numbers | 175010712 |
| Model numbers | 691223 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2215-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.