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Somatic Gene Mutation Detection System
FDA product code OWD · Class 3 · Unknown
24
Registered devices
147
Adverse events
13
Recalls
0
510(k) clearances
Devices with this code
therascreen® BRAF RGQ PCR Kit — QIAGEN GmbHRealTime — ABBOTT MOLECULAR INC.cobas® DNA Sample Preparation Kit — Roche Molecular Systems, Inc.therascreen® EGFR RGQ PCR Kit — QIAGEN GmbHLeukoStrat — INVIVOSCRIBE, INC.cobas® 4800 BRAF V600 Mutation Test — Roche Molecular Systems, Inc.therascreen® PDGFRA RGQ PCR Kit — QIAGEN GmbHtherascreen® FGFR RGQ RT-PCR Kit — QIAGEN GmbHRealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.therascreen® FGFR RGQ RT-PCR Kit — QIAGEN GmbHTHxID™ BRAF — BIOMERIEUX SARealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.cobas® EZH2 Mutation Test — Roche Molecular Systems, Inc.cobas® EGFR Mutation Test — Roche Molecular Systems, Inc.therascreen® PIK3CA RGQ PCR Kit — QIAGEN GmbHLeukoStrat — INVIVOSCRIBE, INC.cobas® EGFR Mutation Test v2 — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.THxID™-BRAF — BIOMERIEUX SALeukoStrat — INVIVOSCRIBE, INC.therascreen® KRAS RGQ PCR Kit — QIAGEN GmbHcobas® KRAS Mutation Test — Roche Molecular Systems, Inc.
Recent 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 ne |
| 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. |
| 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. |
| 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. |
| 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 mo |
| 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 mo |
| 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 describ |
| 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" (i |
| 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) |
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