Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer

Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.

On or about 03/20/2025, the firm sent via email or postal mail an Urgent Medical Device Recall letters informing customers that Beckman Coulter has determined that the DxC 500 AU Clinical Chemistry Analyzer may not run a requested calibration order for a two-part reagent and subsequently prevents any new calibration order from being placed. For two-part reagents, when reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. The analyzer will not allow additional calibration orders to be requested for any assays. Customers are instructed to: . Do not place calibration orders when the analyzer is processing samples. . Refer to the DxC 500 AU IFU Reagent Overview section for instructions on Monitoring the Status of Reagents. . Beckman Coulter recommends sharing the content of this letter with their laboratory and/or Medical Director. . If they experience this issue on software version 1.3, 1.4, 1.4.1 or 1.4.2, contact Beckman Coulter for service. . Beckman Coulter recommends posting this Recall Letter on or near the affected systems until the corrections have been made. Resolution: . This has been resolved in software version 1.4.3 in December of 2024. . Your Beckman Coulter service representative will contact you to schedule the software upgrade. For questions - contact Customer Support Center at: . From our website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633

• FDA enforcement recordOfficial FDA database entry for Z-1784-2025
• FDA 510(k) clearance · K220977The 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.