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Recall Observatory FDA recall evidence

Device 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

Z-2246-2023

May 19, 2023

Class II

Product summary

Firm
Qiagen GmbH
Event
Event 92609
Status
Ongoing
Classification
Class II
Quantity
4155 kits
Official record key
device-enforcement:Z-2246-2023

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: LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 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