Recall archive / FDA device enforcement
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sam... — FDA record Z-2245-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
- Classification
- Class II
- Recalling firm
- Qiagen GmbH
- Quantity
- 386 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2245-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 2, 2023
- Recall initiation date
- May 19, 2023
- Center classification date
- Jul 27, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.