Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21358
Brand Name:Unicell DxH Coulter Cellular Analysis System
Model:
Affected:UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System
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:There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:28/4/2017
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