Qiagen GmbH: 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

Hazard

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

Details from the source

Reason for recall: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Distribution: DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA Quantity: 386 kits Lot/code info: GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17

UPC codes

14053228038846

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.