Recall archive / FDA device enforcement
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 — FDA record Z-0455-2022
Reported terminated
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 Nov 8, 2021. 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 under FDA EUA 200075); REF 691223
- Reason
- The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
- Classification
- Class II
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 376 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0455-2022
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 | LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
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
- Jan 12, 2022
- Recall initiation date
- Nov 8, 2021
- Center classification date
- Jan 5, 2022
- Termination date
- Mar 29, 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.