Recall Z-0951-2022 ยท OWD Somatic Gene Mutation Detection System
Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
| Date | Feb 25, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Qiagen issued Urgent Medical Device Correction therascreen KRAS RGQ PCR Kit (24), REF 870021 letter on 2/25/22. Letter states reason for recall, health risk and action to take: This notice is only relevant for the analysis of samples originating from non-small cell lung cancer (NSCLC) tissue. For continued use of the therascreen KRAS RGQ PCR Kit (24), check the Flags/Warnings in the Sample Result table for automated interpretation of results. Sample results with one or more of the Flags/Warnings listed in this notice should be regarded as invalid with respect to the KRAS status and KRAS Mutati |
| Quantity | 435 kits |
| Distribution | AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.