Coaguchek XS Strips (2018-10-10)

Starting date:

October 10, 2018

Posting date:

November 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68214

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  Reason
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  Affected products

Affected products

Coaguchek XS Strips

Reason

Since the new WHO reference standard rtf/16 is used for calibration of the CoaguChek XS strips, measurement deviations against non-Roche controls as well as laboratory methods for higher INR values have been documented. For values higher than 4.5 INR increasing positive bias was found for identified lots.

Affected products