Beckman Coulter, Inc. recalls DxC 500i Clinical Analyzer Modules

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)

An URGENT MEDICAL DEVICE RECALL notification letter dated 9/12/25 was sent to customers. " When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required. " Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information. " Beckman Coulter suggests sharing this letter with your Medical Director to determine if performing a retrospective review of results is necessary. " Beckman Coulter is investigating the root cause of this issue and will implement a correction with a future software release. " Your Beckman Coulter service representative will contact you to schedule the software upgrade when it is available. 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. If you have any questions regarding this notice, please contact Customer Support Center: " From our website: http://www.beckmancoulter.com

• FDA enforcement recordOfficial FDA database entry for Z-0215-2026
• FDA 510(k) clearance · K242190The device's official FDA premarket clearance record
• FDA device classification · CGROfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1205The 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.