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Qiagen Sciences LLC recalls therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be elig
Recalled February 3, 2021 · FDA recall Z-0937-2021 · Qiagen Sciences
Hazard
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. · FDA Class II
Units
575 kits US
Sold at
CA, IN, MI, MN, NC, NJ, NM, OH, TX
Description
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.
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(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →