medical Class II Updated 2022-04-27

Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, no

Recalled Product

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


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
View official government recall

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