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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Complaint states the opb1 ssp aiiset gold kit has a false negative in lane 39 which gives no perfect match typing result for the opb 1 *135:01 allele. internal investigation has confirmed with the now available rare sample type that it is lane 27 which is negative for the opb 1 *135:01 allele not lane 39 in the above listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a opb1 *135:01 sample.