DxC 500i Clinical Analyzer Software Defect Causes Test Status Display Errors
The DxC 500i clinical analyzer has a software bug affecting 116 units distributed internationally. When Chemistry and Immunoassay tests run simultaneously, test status may incorrectly remain 'In Progress' without error messages, causing processing delays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a medical device used for clinical testing. While no illnesses or injuries have been reported, the software defect creates a risk of harm by providing incorrect status information, which could delay diagnosis or lead to confusion about test completion.
Plain-English summary
Beckman Coulter Inc. is recalling the DxC 500i Clinical Analyzer AU Module (models C63522 and C6352 with software versions 1.3.3 or 1.3.4) due to a software defect affecting test status display.
When a Clinical Chemistry combination test is ordered simultaneously with an Immunoassay test, and the Immunoassay test is processed between the Chemistry tests, the Chemistry sample will incorrectly remain displayed as 'In Progress' without error messages. This causes processing delays.
The recall involves 116 units distributed to 31 countries internationally. No illnesses or injuries have been reported.
The recalled product
- Product
- DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- status-display-error
- processing-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF/UDI-DI: C63522/14987666545089
- C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Distribution
Distribution scope not specified by the agency.
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