Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:34834
Brand Name:DxC 500i Clinical Analyzer
Model:Access 2 Module, DxC 500i - SW v1.3.0 and 1.3.2
Affected:
Software version:
Recalling Organisation:Beckman Coulter NZ Ltd
Suite 2, Level 4
30 St Benedicts Street
Newton
AUCKLAND
Contact Information:0800 446 109
Manufacturer:Beckman Coulter Inc
Issue:The manufacturer has determined that during Installation of the DxC 500i Clinical Analyzer by the Service Engineer, if the analyzer was configured with regional settings, where the region uses commas as decimal identifiers, information within the APF (Assay Protocol File) will load decimal numerals as whole numbers (example 1.25 will load as 125).
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/3/2025
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