Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21509
Brand Name:Siemens Calibrator 30
Model:
Affected:Calibrator 30 kit lots ending in 21
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 determined that samples with estradiol concentrations of approximately 35 pg/mL (128 pmol/L) and lower exhibit a % bias greater than the expected historical performance of the product when comparing C3021 to C3020. Results observed indicate that as estradiol concentrations increase, the % biases observed become less pronounced.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:9/6/2017
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