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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The manufacturer has identified during internal investigation related to a customer complaint a new interference for igg and igm on the elecsys tsh ft4 and ft3 assays.
Model Catalog: 11731459122 (Lot serial: STARTING FROM LOT 165385-04); Model Catalog: 03051986190 (Lot serial: STARTING FROM LOT 164774-03); Model Catalog: 11731297122 (Lot serial: STARTING FROM LOT 165193-04)