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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Cartridge error 1.08 indicating a reference reading outside the electronic limits may result in clinically significant high readings of glucose and lactate results.
Model Catalog: (Lot serial: SN 18410 in inventory); Model Catalog: (Lot serial: units with SN beg. with 18412); Model Catalog: (Lot serial: SN 18405 in inventory); Model Catalog: (Lot serial: SN 18408 in inventory)