Home / Recalls / Medical Devices
Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Recalled April 27, 2022 · FDA recall Z-0952-2022 · Qiagen Sciences
Hazard
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. · FDA Class II
Units
8 Kits
Sold at
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
Description
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.
Product
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Manufacturer(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →