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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01289-1
Product Name/Description	Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD) INRatio Test Strips Reference Numbers: HS0100071, HS0100139, HS099007EU, HS99007G1, HS099008EU, HS99008G1 Multiple Product Descriptions ARTG Number: 216755 INRatio2 Monitors Reference Numbers: HS0200431, HS200433SJM, HS200433SJMK, HS0200433 Multiple Product Descriptions ARTG Number: 214252
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	10/12/2014
Responsible Entity	Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue	In certain cases an INRatio & INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions.br /br /Further information has been published on the TGA website at - http://www.tga.gov.au/alert/alere-inratio-ptinr-monitor-system .
Recall Action	Recall for Product Correction
Recall Action Instructions	Alere is advising consumers and healthcare professionals of the additional warnings and precautions required when using the INRatio & INRatio2 PT/INR Monitor systems. Consumers are requested to consult their doctor to determine if any of the following conditions apply to them: - Anaemia (haematocrit < 30%) - chronic inflammatory conditions - severe infection - advanced stage cancer or end stage renal disease - any bleeding or unusual bruising. This action has beenclosed-out on 06/07/2016.
Contact Information	07 3363 7711 - Alere