Class 2 Device Recall Beckman Coulter

• Date Initiated by Firm: July 15, 2026
• Date Posted: August 17, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2974-2026
• Recall Event ID: 99436
• 510(K)Number: K220977
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
• Code Information: 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Ian Pilcher; 443-350-6459
• Manufacturer Reason for Recall: a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice (dated 7/10/26) to its consignees on 7/15/2026 via USPS and/or email. The notice explained the issue, impact, and requested the following: The customers are advised to: " Do not change any of the 25 predefined calculated rules. In the case that the default expression does not meet the laboratory s requirements, Beckman Coulter has developed a Job Aid, which outlines the workflow required if laboratories require calculated test rules outside of those predefined calculated rules. " Consult with the Laboratory Manager and/or Medical Director to determine whether any of the predefined rules in the table were modified from the default expression during or following analyzer installation. o If no default expression was modified, there is no action to be taken. o If a predefined calculated rule was modified as compared with the default expressions in the table, follow the steps in the letter to configure this rule as a custom calculated rule in System configuration and to disable the predefined calculated rule that was modified. " Share the letter with the Medical Director to determine if performing a retrospective review of results is necessary. " Post the letter on or near the affected analyzers. For questions regarding this notice, please contact our Customer Support Center. " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.
• Distribution: Worldwide distribution - US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE