Home › Beckman Coulter, Inc. › Access Digoxin Calibrators
Access Digoxin Calibrators
Beckman Coulter, Inc. · Model 33715 · UDI-DI 15099590225780
KXT
Prescription
10
510(k) clearances
478
Adverse events (1 deaths)
7
Recalls
23
Facilities
Description
The Access Digoxin Calibrators are intended to calibrate the Access Digoxin assay for the Quantitative determination of digoxin levels in human serum using 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.