Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:35834
Brand Name:DxI 9000 Access Immunoassay Analyzer
Model:
Affected:SW 1.22 and below
Software version:
Recalling Organisation:Beckman Coulter Australia Pty Ltd
1 Dale Street
Brookvale
NSW 2100
Australia
Contact Information:
Manufacturer:Beckman Coulter Inc
Brand Name:DxC 500i Clinical Analyzer
Model:Access 2 Module, DxC 500i -
Affected:SW v1.3.5 and lower
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 the analyzer may fail to apply a dilution factor to tests associated with a manually diluted sample when the tests are ordered through the Test Order Entry page and a unique sample ID is not used.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:25/9/2025
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