DxI Immunoassay Analyzer Motor Configuration Error May Delay Lab Results
Beckman Coulter DxI 800 analyzers may have incorrect motor current settings that reset during software updates, potentially delaying patient sample result reporting.
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 device recall with no reported illnesses, injuries, or hospitalizations. The hazard is theoretical—configuration errors that could delay critical lab result reporting—and falls within the rubric category of 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Beckman Coulter has recalled DxI 800 Access Immunoassay Analyzer systems (Part Number A71456) due to a software configuration error affecting the Pick and Place (PnP) X-motor current settings.
The defect affects systems running software version 5.7 and later. The PnP X-motor current incorrectly resets to 1.5 amperes instead of the required 2.0 amperes. This reset occurs during software installation or upgrades, when the software overwrites the factory-set motor current value.
The incorrect motor current setting causes increased motion errors in the Pick and Place gantry. If undetected, these errors could result in delays in reporting patient sample test results.
The recall affects 451 analyzer systems distributed worldwide, including across the United States. This is an FDA Class II medical device recall assigned reference number Z-2268-2025.
The recalled product
- Product
- DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- configuration-error
- motion-error
- delayed-sample-reporting
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 (1)
- UDI-DI: 15099590369194
Distribution
Distributed nationwide across the United States.
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