Qiagen recalls KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD) due to potential false positive/negative mutation results. Affected units may need retesting for accurate genetic testing.
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) REF 874052 for possible false mutation results. This could lead to incorrect genetic testing outcomes, especially for G12C mutations. Users should verify results with their healthcare provider.
The kit may produce false positive or negative results for G12C mutations in KRAS testing. This happens when Flags/Warnings in the test process invalidate results for certain mutation targets. Incorrect results could lead to wrong treatment decisions.
Users of this genetic testing kit in Japan (not sold in the USA) who may have received results for KRAS mutations. Those with specific cancer testing needs are most at risk of incorrect results.
Check for the product name 'therascreen KRAS RGQ PCR Kit (24)' with reference number REF 874052. This kit was sold in Japan as an IVD product and not released in the USA.
Contact your healthcare provider to confirm if your KRAS mutation test results are accurate, especially for G12C mutations.
No, this kit was sold in Japan as an IVD product and not released in the USA.
Flags or warnings in the test process may invalidate results for specific mutation targets, leading to false positive or negative results for G12C mutations.
No, the recall does not require stopping use. However, you should verify results with your healthcare provider.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-0952-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-0952-2022 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.
