Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results
Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a diagnostic accuracy issue where false negative results could delay cancer diagnosis and treatment decisions. However, the source text contains no reports of actual illnesses, injuries, or adverse clinical outcomes. Per the severity rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
Qiagen GmbH is recalling therascreen KRAS RGQ PCR Kits with expiration dates of March 2023 or later. These kits are used on Rotor-Gene Q MDx instruments to detect seven somatic mutations in the human KRAS oncogene, a genetic marker commonly evaluated in cancer diagnosis and treatment planning.
Revision 13 of the product handbook contains an ambiguous instruction that could lead to false negative test results. When a sample receives a SAMPLE_INT_CTRL_FAIL flag, the handbook indicates that a dilution step should be performed. However, diluting control tissue samples in this scenario could result in false negative results—meaning the test may fail to detect KRAS mutations that are actually present in the sample.
The affected kits were distributed in the United States (Arizona, California, Florida, Illinois, Indiana, Kansas, Massachusetts, North Carolina, New York, Oregon, Pennsylvania, Tennessee, and Texas) as well as internationally in South Korea and China.
The recalled product
- Product
- 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)
- Manufacturer
- Qiagen GmbH
- Hazard
- false-negative
- diagnostic-inaccuracy
Distribution
Distributed nationwide across the United States.
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