Cyclosporine
Clinical Chemistry · 21 CFR 862.1235
Recent MDR events
234 adverse event reports on file
- ARCHITECT CYCLOSPORINE REAGENT KITJun 29, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00099
- ARCHITECT CYCLOSPORINE REAGENT KITJun 29, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00100
- ATELLICA IM CYCLOSPORINE (CSA)Jan 20, 2026MalfunctionSiemens Healthcare Diagnostics Inc1219913-2026-00021
- ATELLICA IM CYCLOSPORINE (CSA)Jan 20, 2026MalfunctionSiemens Healthcare Diagnostics Inc.1219913-2026-00022
- ARCHITECT CYCLOSPORINE REAGENT KITSep 30, 2025MalfunctionAbbott Ireland Diagnostics Division3008344661-2025-00136
- ARCHITECT CYCLOSPORINE REAGENT KITSep 4, 2025MalfunctionAbbott Ireland Diagnostics Division3008344661-2025-00125
- ARCHITECT CYCLOSPORINE REAGENT KITAug 8, 2025MalfunctionAbbott Ireland Diagnostics Division3008344661-2025-00110
- ARCHITECT CYCLOSPORINE REAGENT KITMay 1, 2025MalfunctionAbbott Ireland Diagnostics Division3008344661-2025-00059
- ARCHITECT CYCLOSPORINE REAGENT KITMar 27, 2025MalfunctionAbbott Laboratories1415939-2025-00010
- DIMENSION®Feb 26, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2025-00031
Event type breakdown
Recalls
5 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
ADVIA Centaur Cyclosporine
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
Z-1687-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 21, 2014
Dimension Vista CSA and CSAE
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
Z-1647-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedJan 23, 2014
Dimension Vista Cyclosporine Flex reagent cartridge
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Z-0818-2014 · View FDA record ↗ - Abbott LaboratoriesTerminatedNov 4, 2011
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human who
The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
Z-0162-2012 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedApr 15, 2011
Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapo
The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.
Z-1998-2011 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Fujirebio Diagnostics, Inc.
Seguin, TX, US
Microgenics Corporation
Fremont, CA, US
Fujirebio Diagnostics, Inc.
Malvern, PA, US
Abbott Laboratories
Lake Forest, IL, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Abbott Laboratories
Abbott Park, IL, US
Inpeco Sa
Novazzano Ticino, CH
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
9 clearances for this product code
- Fujirebio Diagnostics,Inc.Sep 11, 2008
K080751 · ARCHITECT CYCLOSPORINE
- Siemens Medical Solutions DiagnosticsSep 11, 2008
K071455 · ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- Siemens Healthcare Diagnostics, Inc.Aug 5, 2008
K081992 · DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- Dade Behring, Inc.Aug 21, 2006
K062236 · DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
- Dade Behring, Inc.Feb 6, 2006
K053061 · EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Dade Behring, Inc.Sep 1, 2005
K052017 · CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
- Abbott Laboratories, Inc.Apr 30, 2004
K040761 · AXSYM CYCLOSPORINE
- Microgenics Corp.Oct 24, 2002
K023208 · CEDIA CYCLOSPORINE PLUS ASSAY