Recall archive / FDA device enforcement
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) — FDA record Z-0951-2022
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 Feb 25, 2022. 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
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Reason
- False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
- Classification
- Class II
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 435 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0951-2022
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 | All lot numbers. GTIN number: 04053228002048 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
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
- Apr 27, 2022
- Recall initiation date
- Feb 25, 2022
- Center classification date
- Apr 18, 2022
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.