MEDICAL DEVICE ALERT – CoaguChek Test Strips

A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain types of CoaguChek Test Strips for Point of Care and Home Use

MEDICAL DEVICE ALERT

Ref: MDA/2018/033

9 October 2018

 CoaguChek Test Strips

(Manufactured by Roche Diagnostics GmbH)

A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain types of CoaguChek Test Strips for Point of Care and Home Use. The affected strips may potentially give false high results for INR values above 4.5 (compared to laboratory results) which may lead to incorrect treatment outcomes.

The table below shows the details of the affected strips:

Further information can be found on the MHRA section on the GOV.UK website.

Produced by NPA Pharmacy team October 2018.