Qiagen recalls Therascreen FGFR RGQ RT-PCR Kit (CE IVD) due to increased false positives, which could lead to incorrect cancer treatment decisions. Affected kits 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 is recalling its Therascreen FGFR RGQ RT-PCR Kit because it can produce false positive results. This might cause patients to receive incorrect cancer treatments or experience unnecessary side effects.
The kit can give false positive results, meaning a patient might be incorrectly told they have cancer when they don't. This could lead to inappropriate treatments or side effects. The risk is specific to the lab's interpretation of the test results.
Patients using this kit for cancer testing in labs that follow CE IVD standards. Those most at risk are individuals who received results from the recalled kit.
Check for the lot number 172017804 and expiration date 10.11.2022 on the kit. This kit is sold in Europe under CE IVD standards and not available in the US.
Look for lot number 172017804 and expiration date 10.11.2022 on the kit packaging.
No, this kit is sold in Europe under CE IVD standards and not available in the US.
A false positive result could lead to the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects.
Check for lot number 172017804 and expiration date 10.11.2022 on the kit packaging.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1651-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1651-2022 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
