Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used Recalled by Qiagen GmbH Due to Handbook Revision (Rev13) a dilution step is indicated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qiagen GmbH directly.
Affected Products
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
Quantity: N/A
Why Was This Recalled?
Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qiagen GmbH
Qiagen GmbH has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report