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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.