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Recall Observatory FDA recall evidence

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

May 19, 2023

Class II

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

    reason.no_named_rule · v1.0.0

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