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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Ocd has received customer complaints of lower than expected results when using lot 1529-17-2636 of vitros chemistry products hcy reagent (code 6802002). internal investigation confirmed that negatively biased results for homocysteine (hcy) could be obtained using the affected lot. as a result ocd is instructing customers to discontinue using and discard all vitros hcy reagent lot 1529-17-2636 remaining in their inventory.