FDA recall Z-0937-2021

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

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.

Distribution

CA, IN, MI, MN, NC, NJ, NM, OH, TX

Key facts

Status

Terminated

Initiation date

2020-12-11

Report date

2021-02-03

Termination date

2022-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2021