Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Tremblay harrison is a private label manufacturer of the stw-a1. we were notified on september 182011 by the manufacturer innovacon inc. that they are undertaking a voluntary recall of the tests as they have discovered an elevated incidence of false positive results. a false positive result could lead to the administration of antibiotics that are unnecessary. this exposes the patient to potential side effects or allergic reaction. these are rarely serious and are usually resolved with discontinuation of medication. as with all diagnostic tests all results must interpreted together with other clinical information available to the physician. the health hazard evaluation has concluded that the overall health risk is low.