Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21315
Brand Name:ADVIA Centaur Systems Insulin assay
Model:
Affected:Catalogue numbers, 10310438 and 10310439
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
Millennium Centre, Part Level 2, Building A
600 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare Diagnostics Inc
Issue:The manufacturer has identified that current in-date lots of ADVIA Centaur Systems Insulin recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. This issue has been corrected and standardization to WHO 1st IRP 66/304 has been restored beginning with ADVIA Centaur IRI ReadyPack kit lots ending in 201 when paired with IRI Calibrator kit lots ending in 02, which will be available by May 2017.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:11/4/2017
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