Z-2973-2026Class II

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module...

Name: Z-2973-2026 Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module...
Creator: Beckman Coulter Inc.
Published: 2026-07-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-07-15 / Open, Classified / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU... on 2026-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2973-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-15
Posted: 2026-08-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root 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.
Product codes and lots: 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2973-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2973-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-17
Z-2974-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-17

Product code JJE

K242190Class IIAccess Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. / cleared 2025-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)