Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:13149
Brand Name:Sysmex CS-2100i/ 2000i Systems
Model:
Affected:all systems with software versions up to and including SW 00-60
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
55 Hugo Johnston Drive
Penrose
Auckland
Contact Information:0800 310 300
Manufacturer:Sysmex Corporation
Issue:Manufacturer advises that CS-2000i and CS-2100i with software version 00-60 show the phenomenon that certain results with error flags highlighted for review, are automatically validated and sent to the host computer without those flags.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:21/7/2012
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