Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28774
Brand Name:Inhibin B Gen II ELISA
Model:
Affected:Lots - 210520C, 210716C, 210823C
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 manufactuere has determined that the Inhibin B Gen II ELISA lots may have higher value of blank which can have a negative impact on sensitivity. Also Control sample 1 could be influenced and found out of acceptable range.
Recall action type:Correction
Recall action:Product to be exchanged
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/12/2021
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