Recall archive / FDA device enforcement
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 — FDA record Z-1652-2022
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 Jul 20, 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
- FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
- Reason
- Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
- Classification
- Class II
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 9 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1652-2022
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 number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
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
- Sep 7, 2022
- Recall initiation date
- Jul 20, 2022
- Center classification date
- Aug 29, 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.