Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:26962
Brand Name:Freelite Kappa/Lambda
Model:
Affected:Lot 432689, expiring Nov 2021
Software version:
Recalling Organisation:The Binding Site Limited
Grant Thornton New Zealand Ltd
L4, 154 Fanshawe Street
Auckland 1010
Contact Information:
Manufacturer:The Binding Site Group Ltd
Issue:The manufacturer has confirmed that the high and low controls provided with the products with lot numbers listed above are consistently demonstrating a positive bias of approximately 15% compared to their assigned values. Customers may experience QC results consistently reporting results close to its upper acceptable limits, and QC failures may occur on affected lots.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:4/12/2020
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