Beckman Coulter DxI 9000 Analyzer May Lose Communication with Laboratory System
The Beckman Coulter DxI 9000 Access Immunoassay Analyzer may lose communication with laboratory information systems under certain conditions, interrupting sample processing and delaying patient test result reporting. This could delay patient treatment.
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 recall for a medical device with documented functional hazard affecting patient care. While no illnesses or injuries have been reported, the risk-of-harm is clear: communication loss prevents timely laboratory result reporting, potentially delaying critical treatment decisions.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer due to a potential communication malfunction. Approximately 370 units worldwide with system software versions SW 1.20.0 and below are affected.
The analyzer may lose communication with a connected host system (laboratory information system or middleware) when it has accumulated canceled quality control test results that were not sent by the LIS. This communication loss interrupts sample processing.
When communication is disrupted, the reporting of patient test results is delayed. This delay in result reporting may subsequently delay patient treatment decisions.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- communication-failure
- delayed-test-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 15099590732103
- all units run with system software versions SW 1.20.0 and below
Distribution
Distribution scope not specified by the agency.
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