Device 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
Z-2245-2023
Product summary
- Firm
- Qiagen GmbH
- Event
- Event 92609
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 386 kits
- Official record key
device-enforcement:Z-2245-2023
Official wording
Reason: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Code information: GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17
Distribution pattern: 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
Derived failure modes
-
Unknown
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated