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 determined that the quality control (qc) value card lists incorrect standard deviation (sd) values for the access amh qc kit lot 689202.The qc value cards for this lot list the following standard deviation values: qc1 as 0.02 qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15 qc2 is 0.76 and qc3 is 2.30.