Cyclosporine
Siemens Healthcare Diagnostics Inc.'s record for this product code
Recent MDR events
26 adverse event reports on file
- ATELLICA IM CYCLOSPORINE (CSA)Jan 20, 2026Malfunction1219913-2026-00021
- ATELLICA IM CYCLOSPORINE (CSA)Jan 20, 2026Malfunction1219913-2026-00022
- DIMENSION®Feb 26, 2025Malfunction2517506-2025-00031
- DIMENSION CYCLOSPORINE FLEX® REAGENT CARTRIDGEJul 9, 2024Malfunction2517506-2024-00180
- DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGEJul 1, 2024Malfunction2517506-2024-00176
- DIMENSION®Jun 2, 2023Malfunction2432235-2023-00132
- ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAYApr 17, 2018Malfunction1219913-2018-00130
- DIMENSION VISTASep 28, 2016Malfunction2517506-2016-00325
- ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAYFeb 29, 2016Malfunction1219913-2016-00048
- DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEMMar 21, 2014Malfunction2517506-2014-00044
Recalls
3 recall events for this product code
- TerminatedMay 4, 2018
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
View FDA record ↗ - TerminatedMay 21, 2014
A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C
View FDA record ↗ - TerminatedJan 23, 2014
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
View FDA record ↗
510(k) clearances
1 clearances for this product code