therascreen KRAS RGQ PCR Kit — Class II medical device recall Z-0952-2022
Ongoing recall by Qiagen Sciences LLC, reported 2022-04-27, distributed in AZ, CA, CT, FL, GA, IL, IN, MA…. False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flag
| Recall number | Z-0952-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-04-18 |
| Reported by FDA | 2022-04-27 |
| Distributed | AZ, CA, CT, FL, GA, IL, IN, MA, MN, NC, NY, OK, OR, PA, TN, TX, WV |
| Quantity | 8 kits |
| Model numbers | 874052 |
Product
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0952-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.