Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27851
Brand Name:ACE Control Se
Model:
Affected:REF 1667001 (lots 80516, 80635, 90092, 90599, 00118, 00360, 00610, 00702)
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:ACE Control Set, failed to reach their stability claim after reconstitution of the quality control material. An upward shift has been observed during testing, up to a maximum of 25.5% of Level 1 and up to 12.5% of Level 2 with lot 90092.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/6/2021
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