Qiagen recalls Therascreen EGFR RGQ PCR Kit (24) due to rare false mutation positive results from fluorescence artefacts. All lots affected. No remedy specified.
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
Qiagen is recalling its Therascreen EGFR RGQ PCR Kit (24) because it can occasionally produce false positive results for mutations. This could lead to incorrect genetic testing conclusions in rare cases. The recall affects all lots of this product.
The kit can produce false positive mutation results due to a fluorescence artefact in rare cases. The controls in the test work correctly, but the mutation assay shows an incorrect positive result. This error is uncommon but could lead to inaccurate genetic findings.
Users of this genetic testing kit, particularly those conducting EGFR mutation tests, may be affected. Those with the kit from any lot are at risk of false positive results.
Check for the Therascreen EGFR RGQ PCR Kit (24) with Reference Number REF 870121. All lots of this product are affected by the recall.
Identify the kit by its name and reference number to confirm it is affected.
The recall record does not specify any remedy.
The recall states it occurs in rare cases, but does not provide specific frequency.
The recall does not require stopping use; it affects all lots but no remedy is specified.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2290-2020 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2290-2020 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.
