medical Class II Updated 2021-02-03

Qiagen Sciences LLC recalls therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clin

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, IN, MI, MN, NC, NJ, NM, OH, TX
Lot/Code Info: All lots
View official government recall

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