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 that the lipase assay was showing occasionally calibration and qc failures associated to on-board reagent stability that have trigger the need to have the reagent shelf-life to be reduced from 15 to 9 months.
Model Catalog: 07041918190 (Lot serial: All lots); Model Catalog: 11821792216 (Lot serial: All lots); Model Catalog: 11821822216 (Lot serial: All lots)