Recall Z-2665-2023— Qiagen GmbH
Class II · Ongoing
Class II FDA medical device recall by Qiagen GmbH, initiated 2023-08-22. FDA's recall record names no specific 510(k) clearance for this event. 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). 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.
- Recalling firm
- Qiagen GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-22
- Firm location
- Hilden, N/A, Germany
Product description
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)
Reason for recall
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
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