Qiagen recalls KRAS RGQ PCR Kit (24) Model REF 870021 due to false positive/negative results for KRAS mutations, potentially invalidating test outcomes.
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Qiagen is recalling its KRAS RGQ PCR Kit (24) with model number REF 870021 because it can produce false positive or negative results for KRAS mutations. This could lead to incorrect test outcomes, which might affect medical decisions.
The kit may give false positive or negative results for KRAS mutations, especially G12C (12CYS) variants. This can invalidate test results for specific mutation targets, potentially leading to wrong medical conclusions.
Lab users and healthcare professionals who test for KRAS mutations with this specific kit are affected. Those using the kit for cancer diagnostics are most at risk of incorrect results.
Check for the model number REF 870021 on the kit packaging. The product was sold in the US as an IVD (in vitro diagnostic) kit with GTIN 04053228002048.
Verify the model number REF 870021 on the kit packaging to confirm if it's affected.
The kit may produce false positive or negative results for KRAS mutations, which could invalidate test outcomes for specific mutation targets.
Check the model number on the packaging. If it's REF 870021, contact Qiagen for guidance on next steps.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-0951-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-0951-2022 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.
