Recall Z-2246-2023— Qiagen GmbH

Name: FDA recall Z-2246-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class II · Ongoing

Class II FDA medical device recall by Qiagen GmbH, initiated 2023-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated.

Recalling firm: Qiagen GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-05-19
Firm location: Hilden, N/A, Germany

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.