Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.20.0 or older that may lose connection to lab systems, delaying patient test results and treatment.
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.
Beckman Coulter is recalling its DxI 9000 Access Immunoassay Analyzers that have software versions 1.20.0 or older. These analyzers may lose connection to lab systems when canceled test results aren't sent, causing delays in patient test results and treatment.
When the analyzer has canceled test results that weren't sent to the lab system, it may lose connection with the host system. This interruption stops sample processing, which delays reporting patient test results and could delay patient treatment.
Laboratories using Beckman Coulter DxI 9000 Access Immunoassay Analyzers with software versions 1.20.0 or older are affected. Lab technicians and healthcare providers who rely on these analyzers for patient testing are most at risk.
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.20.0 or older. The device has a unique identifier (UDI/DI) starting with 15099590732103.
Contact Beckman Coulter to update the software to version 1.20.1 or newer to fix the connection issue.
Software versions 1.20.0 and older are affected.
The problem may delay reporting patient test results and treatment by interrupting sample processing when canceled test results aren't sent to the lab system.
No, but you should update the software to version 1.20.1 or newer to prevent connection issues.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1664-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
