Qiagen Recalls PIK3CA PCR Kits Due to False Positive Mutation Results
Qiagen Sciences LLC is recalling 575 therascreen PIK3CA RGQ PCR Kits because they may generate false positive results for the Q546R mutation, potentially affecting treatment decisions for breast cancer patients.
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: The recall involves a medical diagnostic device that may produce false positive results, leading to potential misdiagnosis or inappropriate treatment for breast cancer patients. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Qiagen Sciences LLC is recalling 575 units of the therascreen PIK3CA RGQ PCR Kit (23) US IVD product, Reference 873121. The recall covers all lots of the product. These kits are intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result.
The recall was initiated because the kits may generate false positive results for the Q546R mutation. This issue is caused by nonspecific molecular interactions within the Q546R assay that are higher than previously observed and described in the Instructions For Use. False positive results could lead to incorrect clinical decisions regarding patient eligibility for specific cancer treatments.
The affected products were distributed in California, Indiana, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, and Texas. Clinicians and laboratories should stop using the affected kits and contact Qiagen Sciences LLC for further instructions on returns or replacements.
The recalled product
- Product
- therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 575
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 lots
Distribution
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