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Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende
Recalled August 2, 2023 · FDA recall Z-2246-2023 · 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
4155 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 (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
Manufacturer(s)
Qiagen GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →