therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer p...
FDA Recall #Z-0937-2021 — Class II — December 11, 2020
Product Description
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
Reason for Recall
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.
Recalling Firm
Qiagen Sciences LLC — Germantown, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
575 kits US
Distribution
CA, IN, MI, MN, NC, NJ, NM, OH, TX
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated