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cobas® KRAS Mutation Test
Roche Molecular Systems, Inc. · Model 1.0 · UDI-DI 00875197004199
OWD
Prescription
0
510(k) clearances
147
Adverse events (1 deaths)
13
Recalls
11
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-22 | Qiagen GmbH | 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 r |
| 2022-07-20 | Qiagen Sciences LLC | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive re |
| 2022-07-20 | Qiagen Sciences LLC | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive re |
| 2022-07-20 | Qiagen Sciences LLC | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive re |
| 2022-02-25 | Qiagen Sciences LLC | 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 mutati |
| 2022-02-25 | Qiagen Sciences LLC | 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 mutati |
| 2021-09-03 | Roche Molecular Systems, Inc. | False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment |
| 2020-12-11 | Qiagen Sciences LLC | Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instru |
| 2016-04-05 | Roche Molecular Systems, Inc. | During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) r |
| 2016-03-15 | Roche Molecular Systems, Inc. | An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas cfDNA |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.