Qiagen therascreen KRAS RGQ PCR Kit Recall: False Positive/Negative Results
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.
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: FDA Class II diagnostic test recall with no reported illnesses or injuries. False positive/negative results in cancer mutation detection create risk of harm through potential treatment errors. Per rubric: 'risk-of-harm products where injury has not yet been reported' = score 3.
Plain-English summary
Qiagen Sciences LLC is recalling all lot numbers of the therascreen KRAS RGQ PCR Kit (REF 874052) in the 24-test package size. This is an in vitro diagnostic test kit designed to detect KRAS G12C mutations, which is used to guide treatment decisions in cancer patients.
The recall was initiated due to a defect that may cause false positive or false negative results in KRAS G12C mutation detection. The issue is related to Flags and Warnings generated during the testing process, which may invalidate results for one or more individual mutation targets.
The product was distributed to facilities in Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and West Virginia.
Users of affected kits should contact Qiagen Sciences LLC for instructions on managing this recall. Patients and healthcare providers who may have received test results from this kit should consult with their healthcare provider regarding the need to verify previous test results.
The recalled product
- Product
- therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- false-positive-result
- false-negative-result
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed in 17 states:
- AZ
- CA
- CT
- FL
- GA
- IL
- IN
- MA
- MN
- NC
- NY
- OK
- OR
- PA
- TN
- TX
- WV
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