Recall Weekly
Moderate riskFDA DeviceClass II

Beckman Coulter DxC 500i analyzers recalled over software defect

Beckman Coulter DxC 500i clinical analyzer modules running software version 1.5 or lower can silently reset custom calculated test rules to their defaults when a new Parameter Package is imported onto a system that already has one. This could produce incorrect patient test results without an error message. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls

What to do

  1. Check whether your lab uses affected DxC 500i modules running software version 1.5 or lower.
  2. After importing any new Parameter Package, verify that custom calculated test rules are still correct before reporting results.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Illnesses reported
None reported
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Classification
Class II
Recall number
Z-2973-2026

In the FDA's words

Description
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 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. 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331. Distribution: Worldwide distribution - US Nationwide.
Hazard
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.

2 products in this recall

Beckman Coulter DxC 500 analyzers recalled for software defect

Beckman Coulter is recalling two products, DxC 500i and DxC 500 AU clinical analyzer modules, when they run software version 1.5 or lower. When a new Parameter Package is imported into an instrument that already has one, custom calculated test rules can silently revert to default settings, which may produce incorrect patient test results without an error message. New installations are not affected, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Beckman Coulter

See all

Related topics

OtherSoftwareMedical devicesSold nationwideMore from FDA Device