Class II — Qiagen Sciences LLC
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) |
| Quantity | 8 Kits |
| Distribution | AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV |
| Initiated | 2022-02-25 |
| Classified | 2022-04-18 |
| Recall number | Z-0952-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qiagen Sciences LLC (Z-0952-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89914/
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