FDA Device recall Z-0951-2022
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) by Qiagen Sciences, citing 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 mutat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0951-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-25 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen Sciences |
| Distribution | AZ, CA, CT, FL, GA, IL, IN, MA, MN, NC, NY, OK, OR, PA, TN, TX, WV |
Product
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
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.
Identifiers
| code_info | All lot numbers. GTIN number: 04053228002048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0951-2022%22
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