Qiagen Sciences LLC Recall 89914
Description: therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Qiagen Sciences LLC Recall 89914 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0952-2022 |
Event ID | 89914 |
Event Description | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) |
Product Type | Devices |
Distribution | AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV |
Quantity | 8 Kits |
Recall 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. |
Device Classification | 20220427 |
Device Code Info | All lot numbers |
Center Classification Date | 20220418 |
Recall Initiation Date | 20220225 |
Recalling Firm | Qiagen Sciences LLC |
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