Qiagen GmbH has initiated a voluntary recall for the therascreen KRAS RGQ PCR Kit (24), a diagnostic tool used to detect somatic mutations in cancer patients. The recall was prompted by an error in the product's handbook (Revision 13) that incorrectly instructs users to dilute samples when a specific internal control error (SAMPLE_INT_CTRL_FAIL) occurs. Diluting certain tissue samples, specifically colorectal cancer (CRC) tissue, can reduce the concentration of the target DNA too much, potentially leading to a false negative test result. This issue affects kits with a GTIN of 04053228002048 and expiration dates of March 2023 or later.
If a sample is diluted as incorrectly instructed by the handbook, the test may fail to detect KRAS mutations that are actually present. This false negative result could lead to inappropriate patient management or the selection of ineffective cancer treatments.
Corrective Action / Handbook Revision
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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