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Recall Observatory FDA recall evidence

Device product

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

Z-0952-2022

February 25, 2022

Class II

Product summary

Firm
Qiagen Sciences LLC
Event
Event 89914
Status
Ongoing
Classification
Class II
Quantity
8 Kits
Official record key
device-enforcement:Z-0952-2022

Official wording

Reason: 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.

Code information: All lot numbers

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.