Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19509
Brand Name:BC Access Ostase Calibration Kit and QC Kit
Model:37305 (Calibrator), 37309 (QC)
Affected:528936 & 528938 (calibrator); 528937 & 528939 (QC)
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 Access Ostase Calibrator and Access Ostase QC lots listed above do not meet their labeled expiration dates when stored after initial use (open vial stability). When stored unopened, calibrators and quality controls are stable until the expiration date on the vials.
Through internal testing, Beckman Coulter has determined that the above lots are stable at 2 to 10°C for 58 days after initial use.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:27/11/2015
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