Device 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
Z-0937-2021
Product summary
- Event
- Event 87047
- Status
- Terminated
- Classification
- Class II
- Quantity
- 575 kits US
- Official record key
device-enforcement:Z-0937-2021
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: CA, IN, MI, MN, NC, NJ, NM, OH, TX
Derived failure modes
-
Unknown
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.