FDA recall Z-0952-2022

Product

therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

Reason for recall

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Distribution

AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

Key facts

Status

Ongoing

Initiation date

2022-02-25

Report date

2022-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2022