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Qiagen Sciences LLC Recall 89914

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

Qiagen Sciences LLC Recall 89914 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0951-2022
Event ID89914
Event Descriptiontherascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Product TypeDevices
DistributionAZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
Quantity435 kits
Recall ReasonFalse 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.
Device Classification20220427
Device Code InfoAll lot numbers. GTIN number: 04053228002048
Center Classification Date20220418
Recall Initiation Date20220225
Recalling FirmQiagen Sciences LLC
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