Qiagen recalls PIK3:3CA RGQ PCR Kit (23) US IVD product due to potential false positive results for breast cancer mutation testing. Affected kits may misidentify patients for PIQRAY treatment.
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Qiagen recalls a breast cancer mutation testing kit that could produce false positive results, potentially misidentifying patients who may be eligible for PIQRAY treatment. This could lead to incorrect treatment decisions.
The kit may generate false positive results for the Q546R mutation due to nonspecific molecular interactions. This could lead to incorrect identification of patients who may be eligible for PIQRAY treatment, potentially causing inappropriate treatment decisions.
Clinicians using the PIK3CA RGQ PCR Kit (23) for breast cancer mutation testing in the US. Those most at risk are patients being evaluated for PIQRAY treatment.
The PIK3CA RGQ PCR Kit (23) is a US IVD product sold for breast cancer mutation testing. All lots are affected, so any kit with this product name is recalled.
Review the lot number on the kit to confirm it is affected (all lots are recalled).
No, this kit helps clinicians identify patients who may be eligible for PIQRAY treatment, which is a breast cancer therapy.
False positive results could lead to incorrect identification of patients for PIQRAY treatment, potentially causing inappropriate treatment decisions.
The recall does not provide a fix; all affected kits must be checked and discontinued.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-0937-2021 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-0937-2021 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.
