Lab Immunoassay Analyzer Software Bug Delays Patient Result Reporting
Beckman Coulter's DxI 600 Access Immunoassay Analyzer has a software defect causing incorrect motor current settings that may delay patient sample result reporting. The issue affects systems running software versions 5.7 and later.
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 with a software defect that can cause motion errors and delays in critical patient diagnostic result reporting. The potential impact on patient care workflow places this in the risk-of-harm category warranting High severity, though no injuries have been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 600 Access Immunoassay Analyzer with dual gantry systems running software versions 5.7 and later. The recall applies to systems distributed worldwide, including nationwide US distribution.
The analyzer has a software defect in which the PnP (pick-and-place) X-motor current setting incorrectly resets to 1.5 amperes instead of the required 2.0 amperes. This occurs because the software overwrites the factory setting during system installation or software upgrades.
This motor current anomaly can cause increased motion errors in the sample-handling system, which may lead to delays in reporting patient sample results if the problem goes unnoticed. Affected users should contact Beckman Coulter to confirm whether their system is impacted and to obtain instructions for correcting the motor current setting.
The recalled product
- Product
- DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- software-defect
- 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 (2)
- UDI-DI: 15099590369248
- Serial Numbers: 902101
Distribution
Distributed nationwide across the United States.
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