Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0937-2021 — 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

U.S. FDA — Device Enforcement · United States · 2020-12-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0937-2021
Date of alert
2020-12-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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