FDA Device recall Z-2245-2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients sus…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients sus… by Qiagen, citing identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2245-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-19 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen |
| Distribution | AL, CA, DC, DE, FL, GA, ID, IN, ME, NC, NY, OR, TN, TX |
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Reason
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Identifiers
| code_info | GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2245-2023%22
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