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Product Safety Information

This page contains important information for customers of the products listed below. It is updated on the rare occasions that customers need to be informed of safety issues with products.

Urgent Field Safety Notice relating to selected Roche Diagnostic products

Notice Posted 07/09/2018

Summary of Field Safety Notice: PFSN18 Deviations of high (>4.5) CoaguChek INR values due to calibration with WHO reference standard rTF/16 SBN-CPS-2018-014

Products affected:

COAGUCHEK XSPT STRIPS X 48

WMS Code: W3690 - Vendor Code: 04625315019

Batch Range: 272167 > 334498


COAGUCHEK XSPT STRIPS X 48

WMS Code: W3690 - Vendor Code: 04625315019

Batch Range: 272167 > 334498


COAGUCHEK XSPT STRIPS X 48

WMS Code: W3690 - Vendor Code: 04625315019

Batch Range: 272167 > 334498


Systems affected:

* CoaguChek® XS system

* CoaguChek® INRange system

* CoaguChek® XS Plus system

* CoaguChek® XS Pro system

* CoaguChek® Pro II system


For full information, please click here.



Disclaimer: all software is provided as is, with no expression of warranty or suitability for a specific purpose.