medical Class II Updated 2022-04-27

Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 8700

Recalled Product

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CT, FL, GA, IL, IN, MA, MN, NC, NY, OK, OR, PA, TN, TX, WV
Lot/Code Info: All lot numbers. GTIN number: 04053228002048
View official government recall

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