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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0951-2022 |
| Event ID | 89914 |
| Event Description | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) |
| Product Type | Devices |
| Distribution | AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV |
| Quantity | 435 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. GTIN number: 04053228002048 |
| Center Classification Date | 20220418 |
| Recall Initiation Date | 20220225 |
| Recalling Firm | Qiagen Sciences LLC |
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