The Medicines and Healthcare products Regulatory Agency (MHRA) said last week there have been ‘no reported adverse incidents' but was due to issue a medical device alert.
In the post-launch study the mobile-phone sized monitors ‘did not produce equivalent performance to the claims in the product labelling,' Unipath said.
Patients' International Normalised Ratio (INR) of blood clotting could be wrongly estimated, putting them at risk of undermedication and the possibility of recurrent thrombosis or embolism.
SmartCheck meters were used by up to 100 surgeries providing near-patient testing for patients on anticoagulation therapy. The surgeries will be invited to switch to the Hemosense INRatio system.
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