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Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample
Recalled August 2, 2023 · FDA recall Z-2245-2023 · Qiagen
Hazard
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated · FDA Class II
Units
386 kits
Sold at
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
Description
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
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
Manufacturer(s)
Qiagen GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →