Class II — Qiagen GmbH
| Recalling firm | QIAGEN, GmbH |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid |
| Product | therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD) |
| Quantity | N/A |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN |
| Initiated | 2023-08-22 |
| Classified | 2023-09-29 |
| Recall number | Z-2665-2023 |
| 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 GmbH (Z-2665-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92991/
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