Genetic Testing Kit Recalled for Inaccurate Mutation Test Results
Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states 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 an FDA Class II medical device recall for a diagnostic kit that can produce false positive or false negative results. No hospitalizations, injuries, or deaths have been reported. The potential for inaccurate test results creates risk of harm through incorrect medical decisions, but without reported illness, this qualifies as a risk-of-harm product where injury has not been reported.
Plain-English summary
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit (Model REF 870021), used in clinical laboratories to detect genetic mutations. The kit identifies the G12C (12CYS) mutation of the KRAS gene.
The kit can produce false positive or false negative results for KRAS mutation status due to flags or warnings that appear during testing. These inaccurate results invalidate the test outcome.
The recall affects 435 kits with all lot numbers. The kits were distributed to clinical laboratories in 16 U.S. states: Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and West Virginia.
The recalled product
- Product
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device — Diagnostic Kit
- Affected units
- 435
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. GTIN number: 04053228002048
Distribution
Part of a larger recall action
This product is one of 2 recalled by Qiagen Sciences LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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