QIAstat-Dx Respiratory SARS-CoV-2 Panel — Class II medical device recall Z-2246-2023
Ongoing recall by Qiagen GmbH, reported 2023-08-02, distributed in AL, CA, DC, FL, GA, ID, IN, ME…. Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample
| Recall number | Z-2246-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen GmbH, Hilden, N/A, Germany |
| Recall initiated | 2023-05-19 |
| Classified | 2023-07-27 |
| Reported by FDA | 2023-08-02 |
| Distributed | AL, CA, DC, FL, GA, ID, IN, ME, NC, NY, OR, TN, TX |
| Quantity | 4,155 kits |
| Lot numbers | 172043034, 172043348, 172043349, 172043369, 172044712, 172046775, 172048091, 172048381, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669 |
| Model numbers | 691214 |
| Expiration dates | 2023-10-06 |
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
Reason for recall
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
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-2246-2023. 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.