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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Immucor inc. is issuing this medical device recall regarding the stability of the tpha screen test cells lot 280006. a review of post-release testing demonstrated this lot of tpha screen test cells had a decrease in sensitivity for detection of antibodies to treponema pallidum over the product's shelf life.