DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Host System Connectivity (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
Products Sold
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
Beckman Coulter, Inc. is recalling Beckman Coulter DxI 9000 Access Immunoassay Analyzer due to When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated cancel. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026