Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22229
Brand Name:DxH500 open-Vial Hematology System
Model:
Affected:Ref B40601
Software version:1.0.2 and 1.1
Recalling Organisation:Beckman Coulter NZ Ltd
Suite 2, Level 4
30 St Benedicts Street
Newton
AUCKLAND
Contact Information:0800 446 109
Manufacturer:Beckman Coulter Ireland Inc
Issue:An internal investigation has identified that if the Bleach Cycle is interrupted or aborted, the DxH 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. Should a Bleach Cycle get interrupted, the subsequent software recovery to perform a Diluter Reset may not be sufficient to prevent the first immediate sample run from being affected.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/11/2017
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /