Pharmacy Daily | INR monitor recall

ALERE, in consultation with the Therapeutic Goods Administration, will be recalling its INRatio PT/INR monitor system, after previous measures to improve the device’s reliability had “not adequately mitigated the identified risks”. The product was recalled for correction in late Dec 2014 after it was identified that in certain cases it could provide an incorrect INR result clinically significantly lower than what would be obtained using a laboratory INR method. In an update issued yesterday the TGA confirmed that despite software improvements and changes to the Instructions of Use the identified risks remain, and based on this and Alere’s business considerations the device is being withdrawn from the market. The TGA is working with Alere on developing the recall strategy “including communication to affected patients and health professionals on safely transitioning to an alternate testing method”. Meanwhile patients are advised to talk to their health professionals before making any changes to their anticoagulation monitoring.

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