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 is recalling its FGFR RGQ RT-PCR Kit (RUO) because it can produce false positive results. This might lead to patients receiving incorrect cancer treatments or experiencing unnecessary side effects.
The kit can generate false positive results, which might lead to incorrect cancer treatment reports. This could cause patients to receive inappropriate or suboptimal treatments or experience unnecessary side effects.
Users of this lab kit, particularly those in cancer testing labs, may be affected. Patients receiving results from this kit could face incorrect treatment decisions.
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).
Verify the lot number (169047135) and expiration dates (12.06.2022 or 10.11.2022) on the kit.
The recall is for potential false positive results, not a safety hazard. The kit is labeled as RUO (Research Use Only), not for clinical use.
The recall does not specify a remedy, so no action is required beyond checking the kit details.
The recall states false positives might lead to incorrect treatments, but no specific harm is mentioned. The danger level is low risk.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1652-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1652-2022 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.
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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.
