Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers beginning on 2/6/25. Beckman Coulter has determined that a DxI 9000 Access Immunoassay Analyzer containing tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. If the analyzer experiences the issue described above, it can lead to the analyzer entering the red, or Stopped, system status due to Reagent Storage and Tip Stocker "axis is out of tolerance" errors. Any in process tests that require addition of reagent at the time of the error are cancelled. There could be a delay in reporting patient test results to the physician. If the error occurs: 1. Confirm that the DxI 9000 Access Immunoassay Analyzer is in either the Paused or Stopped system state. 2. Select the System state button in the lower left corner of the user interface. 3. Select Initialize. When initialization is complete, the analyzer returns to the green, or Running, state. If your laboratory has experienced the issue and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. Beckman Coulter has identified the root cause of this issue and is no longer distributing affected TSI-RSI boards. A Beckman Coulter service representative will schedule a visit to replace any affected TSI-RSI boards on your DxI 9000 Access Immunoassay Analyzer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. I

• FDA enforcement recordOfficial FDA database entry for Z-1387-2025
• 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.