Home › Device types › KXT
Enzyme Immunoassay, Digoxin
FDA product code KXT · Class 2 · Clinical Toxicology
32
Registered devices
478
Adverse events
7
Recalls
85
510(k) clearances
Devices with this code
Elecsys Digoxin Assay — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems DIG Digoxin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess Digoxin Calibrator S0 — Beckman Coulter, Inc.Dimension® Flex® reagent cartridge DGNA — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAlinity — ABBOTT LABORATORIESCobas Elecsys AntiTPO — Roche Diagnostics GmbHElecsys Digoxin — Roche Diagnostics GmbHADVIA® Chemistry DIG Digoxin Reagents — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESADVIA Centaur® DIG — Siemens Healthcare Diagnostics Inc.DRI Digoxin Assay — Microgenics CorporationIMMULITE® 2000 Systems DGX Digoxin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDRI Digoxin Assay — Microgenics CorporationElecsys Digoxin Immunoassay — Roche Diagnostics GmbHAccess Digoxin — Beckman Coulter, Inc.Atellica IM Dig — Siemens Healthcare Diagnostics Inc.Emit® 2000 Digoxin Assay — Siemens Healthcare Diagnostics Inc.Atellica CH Dgn — Siemens Healthcare Diagnostics Inc.ONLINE TDM Digoxin — Roche Diagnostics GmbHADVIA Centaur® DIG +B — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESAccess Digoxin Calibrators — Beckman Coulter, Inc.Tina-quant Digoxin — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-21 | Siemens Healthcare Diagnostics, Inc. | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dime |
| 2013-02-21 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DI |
| 2008-05-22 | Abbott Diagnostic International, Ltd. | AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Dig |
| 2007-07-20 | Abbott Diagnostic International, Ltd. | Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, i |
| 2007-03-30 | Abbott Diagnostic International, Ltd. | Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay. |
| 2007-03-16 | Roche Diagnostics Corp. | The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 n |
| 2005-02-23 | Beckman Coulter Inc | Variability in results on Patient and QC results of 20-25%, high and low. |
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