Immunoassay Analyzer Motor Current Setting Error Causes Motion Delays
Beckman Coulter's DxI 800 immunoassay analyzers with certain software versions have a motor current setting that incorrectly resets during updates, potentially delaying patient test 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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The malfunction causes operational delays in diagnostic result reporting rather than direct patient harm. This meets the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 800 Access Immunoassay Analyzer W/Dual Gantry (Part Number A71457) due to an issue with the X-motor current setting in the analyzer's PnP gantry system.
The issue occurs in systems running software version 5.7 and above. During software installations or upgrades, the software overwrites the factory setting for the PnP X-motor current, resetting it to 1.5A instead of the required 2.0A. This incorrect current setting increases motion errors in the PnP gantry.
These motion errors can delay the reporting of patient sample results if not detected. The DxI 800 analyzer is distributed worldwide and throughout the United States and is used in clinical and diagnostic laboratories.
Laboratories with affected systems should contact Beckman Coulter for instructions on correcting the motor current setting.
The recalled product
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- device-malfunction
- software-error
- diagnostic-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)
- UDI-DI: 15099590369231
- Serial Numbers: 608109
Distribution
Distributed nationwide across the United States.
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