Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21465
Brand Name: N Protein Standard SL and N/T Protein Controls SL
Model:
Affected: Catalogue numbers 10446073, 10446076, 10446082 and 10446086
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
55 Hugo Johnston Drive
Penrose
Auckland
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare Diagnostics Inc
Issue:The manufacturer has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating with specific lots of N/T Protein Standard SL. N/T Protein Controls SL for ceruloplasmin are similarly biased. N Antiserum to Human Ceruloplasmin works as intended. A deviation in the value assignment of the affected standards and controls is leading to a lower result compared to correctly assigned standards.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/5/2017
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