Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:23547
Brand Name:CoaguChek XS PT
Model:
Affected:CoaguChek XS PT Test PST from #272167 up to #334498, CoaguChek XS PT Test from #272167 up to #334498, CoaguChek PT Test from #272170 up to #353606
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:Roche Diagnostics GmbH
Issue:Manufacturer has received an increased number of complaints regarding deviations of CoaguChek test strips against non-Roche controls as well as laboratory methods during the last weeks. Therefore, they have initiated an in-depth analysis in order to determine the reasons for the observed differences.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:5/9/2018
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