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Cyclosporine
FDA product code MKW · Class 2 · Clinical Chemistry
23
Registered devices
234
Adverse events
5
Recalls
9
510(k) clearances
Devices with this code
Atellica IM Multi-Diluent 12 — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge CSAE — Siemens Healthcare Diagnostics Inc.CEDIA Cyclosporine PLUS Assay — Microgenics CorporationAlinity-Architect — ABBOTT LABORATORIESDimension® Flex® reagent cartridge CSAE — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESADVIA Centaur® CsA — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESSyva® Emit® 2000 Cyclosporine Specific Calibrators — Siemens Healthcare Diagnostics Inc.Dimension® CSA Flex® reagent cartridge — Siemens Healthcare Diagnostics Inc.CSAII Cyclosporine II — Roche Diagnostics GmbHSyva® Emit® 2000 Cyclosporine Specific Assay — Siemens Healthcare Diagnostics Inc.Syva® Emit® Cyclosporine Pretreatment Reagent — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESEmit Cyclosporine Sample — FUJIREBIO DIAGNOSTICS, INC.Atellica IM CsA — Siemens Healthcare Diagnostics Inc.CEDIA Cyclosporine-PLUS Assay — Microgenics CorporationDimension Vista® Flex® reagent cartridge CSA — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Multi-Diluent 12 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CsA PRE Pretreatment — Siemens Healthcare Diagnostics Inc.Atellica IM CsA PRE Pretreatment — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIES
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimensio |
| 2014-03-19 | Siemens Healthcare Diagnostics, Inc. | 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- |
| 2013-12-05 | Siemens Healthcare Diagnostics, Inc. | Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges. |
| 2011-10-07 | Abbott Laboratories | The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package |
| 2010-08-13 | Roche Diagnostics Operations, Inc. | The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date. |
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