Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27916
Brand Name:Access AMH Calibrator
Model:
Affected:189303, 189304, 189305, 189306
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 through an internal investigation that the Access AMH Calibrator do not meet the open vial stability claim when used on days 32-90 after reconstitution. The open vial calibrator stability from 0 to 31 days is not impacted.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:21/6/2021
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