DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module
Beckman Coulter, Inc. · Model C63521 · UDI-DI 14987666545072
Description
The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only. The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. C63521 does not include an ISE module.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Beckman Coulter Inc. | Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us |
| 2026-09-02 | Beckman Coulter Inc. | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use |
| 2026-08-03 | Beckman Coulter Mishima K.K. | Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching th |
| 2026-07-15 | Beckman Coulter Inc. | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of |
| 2026-07-15 | Beckman Coulter Inc. | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of |
| 2026-01-20 | Roche Diagnostics Operations, Inc. | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended |
| 2025-11-26 | Beckman Coulter, Inc. | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multi |
| 2025-11-26 | Beckman Coulter, Inc. | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multi |
| 2025-11-13 | Abbott Laboratories | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance i |
| 2025-11-07 | Beckman Coulter, Inc. | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusi |
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