[pending] Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Pending LLM rewrite. Source: FDA_DEVICE Z-1664-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
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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