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Access Digoxin
Beckman Coulter, Inc. · Model 33710 · UDI-DI 15099590225797
10
510(k) clearances
478
Adverse events (1 deaths)
7
Recalls
23
Facilities
Description
The Access Digoxin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of digoxin level in human serum ising the Access Immunoassay Systems.
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 Dimension TNI, Dimension |
| 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 DIGXN with either Drug |
| 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 Digoxin II assay file. |
| 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, is reported for the p |
| 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 ng/mL for all reagent |
| 2005-02-23 | Beckman Coulter Inc | Variability in results on Patient and QC results of 20-25%, high and low. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.