Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer

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 DxI 9000 Access Immunoassay Analyzer

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

• FDA enforcement recordOfficial FDA database entry for Z-1664-2025
• FDA 510(k) clearance · K221225The device's official FDA premarket clearance record
• FDA device classification · JJEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.