QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid… — Class II medical device recall Z-1683-2023
Ongoing recall by Qiagen Sciences LLC, reported 2023-06-14, distributed nationwide. Faulty cartridges in the lot could result in false test results.
| Recall number | Z-1683-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2023-04-28 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 347 kits |
| UPC / GTIN / UDI-DI | 14053228038846 |
| Lot numbers | 175011350 |
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Reason for recall
Faulty cartridges in the lot could result in false test results.
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-1683-2023. 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.