Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid Recalled by Qiagen Sciences LLC Due to Kit may generate false Q546R mutation positive results...
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 Sciences LLC directly.
Affected Products
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
Quantity: 575 kits US
Why Was This Recalled?
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Where Was This Sold?
This product was distributed to 9 states: CA, IN, MI, MN, NJ, NM, NC, OH, TX
About Qiagen Sciences LLC
Qiagen Sciences LLC has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report