FDA recall, , Moderate risk
Beckman Coulter DxC 500I Clinical Analyzer Modules
Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter Inc. of Brea, California, recalled DxC 500 AU Clinical Analyzer Modules and DxC 500i Clinical Analyzer Modules using software version 1.5 or lower, including the DxC 500 AU Clinical Chemistry Analyzers.
A software defect in the Parameter Package import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. This can cause user-customized calculated test rules to revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification.
The recall began July 15, 2026, and was added to the FDA's Enforcement Report on August 17, 2026, with distribution worldwide, including nationwide in the US. Affected products include modules such as the AU w/out ISE and the DxC 500 AU Module w/ISE, DxC 500i.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower
- UDI-DI
- 14987666545089
- 14987666545072
- 15099590742331
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower
- UDI-DI
- 14987666545058
- 14987666545065
From the FDA notice
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
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide.
- Company
- Beckman Coulter Inc.Brea, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99436
- Recall numbers
- Z-2973-2026 to Z-2974-2026
All recalls from Beckman Coulter Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
