Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

On 8/4/2025, recall notices were mailed and/or emailed to customers who were asked to do the following: Check your software version, select Menu - About page. - For Clinical Analyzers running software version 1.3.3 or 1.3.4, if this issue occurs, you will need to place a new order for the CC combination test, - Select Home - Sample List task indicator, then select Active in the upper left corner of the Sample List to display samples "In Progress". - Program the CC combination tests for these "In Progress" samples using a new rack and Sample ID, apply the new barcode, then load the rack onto the analyzer for processing. - Set aside the rack with "In Progress" samples and contact your Beckman Coulter representative to clear them. Firm recommends sharing the content of this letter with your laboratory and/or Medical Director. Firm has resolved this issue in Software version 1.3.5 and a firm service representative will contact you to schedule the software upgrade. 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(s) listed above to another laboratory, please provide them a copy of this letter. Complete and return the response form via email to: regaffairsfax@beckman.com If you have any questions regarding this product, please contact your local firm representative, or use the following link for a listing of local contact information. https://www.beckmancoulter.com/en/support/contact-us

• FDA enforcement recordOfficial FDA database entry for Z-0032-2026
• 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.