Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15654
Brand Name:Siemens BFT II Analyser
Model:Catalogue Number: OVKF03 / SMN 10458677
Affected:
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 Products GmbH
Issue:It has been confirmed that Standard Human Plasma (SHP, REF ORKL) pre-dilution ratios given in the Reference Guides of the BFT* II Analyzer do not correspond to the standard dilution procedure for endogenous coagulation factor determination. The incorrect dilution ratio stated in the Reference Guides is limited to the lowest calibration point.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/11/2013
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