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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Beckman coulter inc. identified an issue with one of the raw materials used to manufacture the coulter act 5diff fix reagent lots: 16602e 16702e and 16802e.
Model Catalog: (Lot serial: 16602E); Model Catalog: (Lot serial: 16702E); Model Catalog: (Lot serial: 16802E); Model Catalog: (Lot serial: REAGENT LOT NUMBERS)