FDA Device recall Z-0952-2022
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
- 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) REF 874052 (Japan IVD, not released in the USA) 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-0952-2022 |
| 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) REF 874052 (Japan IVD, not released in the USA)
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 |
|---|
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-0952-2022%22
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