Enzyme Immunoassay, Digoxin
FDA adverse event reports and recall history for enzyme immunoassay, digoxin (product code KXT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 477
- Deaths
- 1
- Injuries
- 5
- Malfunctions
- 461
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-05-05TerminatedUnder Investigation by firm
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
- 2013-04-18TerminatedProcess control
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
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 DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
- 2008-11-21TerminatedSoftware change control
AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.
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 Digoxin II assay file.
- 2007-11-03TerminatedLabeling design
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.
- 2007-08-29TerminatedOther
Abbott AxSYM System Digoxin III Reagent Pack
Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
- 2007-04-13TerminatedOther
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
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 ng/mL for all reagent lots.
- 2005-03-08TerminatedOther
Access Immunoasay Systems Digoxin Reagent
Variability in results on Patient and QC results of 20-25%, high and low.
Monitor enzyme immunoassay, digoxin automatically
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