UniCel DxI 800 Analyzer Motor Current Settings Incorrectly Reset
Beckman Coulter's UniCel DxI 800 analyzer has a software defect causing the motor current to reset to 1.5A instead of 2.0A during updates, potentially delaying patient sample reporting. Affected devices require remediation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses, injuries, or deaths. The defect causes operational issues that could delay sample result reporting, but poses no direct patient safety hazard. This aligns with Moderate severity for precautionary device recalls without adverse health outcomes.
Plain-English summary
The UniCel DxI 800 Access Immunoassay Analyzer (Part Number 973100) is being recalled. Beckman Coulter identified a software defect affecting systems worldwide that causes the analyzer's PnP (Plate and Pinch) X-motor current to incorrectly reset to 1.5A instead of the required 2.0A during software installations or upgrades.
The defect occurs because the software overwrites the factory-set motor current configuration during installation or upgrade procedures. This results in increased motion errors during sample processing.
The recall affects systems distributed in the U.S. and internationally. Affected facilities should contact Beckman Coulter for remediation. While the incorrect motor current setting could lead to delays in reporting patient sample results if unnoticed, this recall is precautionary and no patient harm has been reported.
The recalled product
- Product
- UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- software-defect
- motion-error
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: 15099590265373
Distribution
Distributed nationwide across the United States.
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