Medical Device Analyzer Motor Settings Error Can Delay Patient Results
Beckman Coulter is recalling 271 UniCel DxI 600/800 analyzers with incorrect motor current settings due to a software issue that could delay patient sample reporting.
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 recall with theoretical hazard—potential delays in patient result reporting—and no reported patient harm, qualifying as a precautionary recall meeting Moderate severity criteria.
Plain-English summary
Beckman Coulter is recalling 271 UniCel DxI 600/800 Access Immunoassay Analyzer systems with linear slide pick-and-place (PnP) gantries running software versions 5.7 and up. The systems have been distributed worldwide, including throughout the US.
The company identified that the PnP X-motor current incorrectly resets to 1.5 amperes instead of the required 2.0 amperes. This occurs because the software overwrites the factory setting during software installations or upgrades. The incorrect current setting causes increased PnP motion errors, which could lead to delays in reporting patient sample results if the errors go unnoticed.
Beckman Coulter has classified this as a Class II recall. Healthcare facilities using affected analyzers should verify their device serial number and software version against the company's recall information and contact Beckman Coulter for instructions on correcting the motor current settings.
The recalled product
- Product
- UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- motor-current-error
- delayed-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: 15099590341602
Distribution
Distributed nationwide across the United States.
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