The Health Canada posted a medical device recall notice concerning ProTime Microcoagulation System, manufactured by International Technidyne Corporation. The affected model is Protimepro and the affected lot is V-71458.
According to the notice, a limited number of ProTime instruments were manufactured with a component that may contribute to a small decrease in performance and may cause inconvenience. The affected instruments have a potential to yield either an Error Code (No test) or a slightly lower than actual PT/INR result when the INR is greater than 3.5.
For details, please refer to Health Canada website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 28 Jun 2012