medical Class II Updated 2023-08-02

Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD,

Recalled 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

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: LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17

View official government recall

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