medical Class II Updated 2023-08-02

Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative

Recalled 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

Hazard / Issue

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Issued by

FDA

Affected States: DC, AL, CA, FL, GA, ME, NC, NY, OR, TX, DE, ID, IN, TN
Lot/Code Info: GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
View official government recall

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