Qiagen recalls FGFR RGQ RT-PCR Kit (RUO) with risk of false positive results causing incorrect cancer treatment reports. Affected units have specific lot numbers and expiration dates.
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
“Qiagen FGFR RGQ RT-PCR Kit Recall: False Positive Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60333-qiagen-fgfr-rgq-rt-pcr-kit-recall-false-positive-results. Based on FDA recall #Z-1652-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1652-2022%22&limit=1).
The FDA announced on July 20, 2022, that Qiagen Sciences LLC is recalling the FGFR RGQ RT-PCR Kit due to false positive results. The agency stated the recall addresses a hazard where incorrect reporting could lead to inappropriate anti-cancer treatment.
How to tell if you have it
Brand: Qiagen
Product: FGFR RGQ RT-PCR Kit (RUO, not IVD)
Reference: REF 8747010
Lot numbers: 169047135, 172017806
Expiration dates: 12.06.2022, 10.11.2022
Quantity: 9 kits
The hazard
The recall addresses an increased occurrence rate of false positive results that could be incorrectly reported from the laboratory. According to the FDA, 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.
Context
GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent brand recalls include the March 12, 2025 recall of the QIAstat-Dx Respiratory Panel Plus for faulty cartridges and the June 3, 2024 recall of the QIAcube Connect MDx for heater shaker module issues. Other recent recalls of similar products include the Exploro Fertility Test Recall (Nov. 22, 2025), the Menopause Test Cassette Recall (Nov. 22, 2025), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for the kit's lot number 169047135 and expiration dates 12.06.2022 or 10.11.2022. The product is labeled as RUO (Research Use Only, not IVD).
Brand
Qiagen
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711; Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022
29 kits
Z-1652-2022
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010; Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022
9 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the lot number (169047135) and expiration dates (12.06.2022 or 10.11.2022) on the kit.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Minnesota, North Carolina, Texas.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1652-2022 (July 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1652-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.