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Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Recalled April 27, 2022 · FDA recall Z-0951-2022 · 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
435 kits
Sold at
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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) Model Number(s): REF 870021 (US IVD)
Manufacturer(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →