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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Siemens healthcare diagnostics has confirmed complaints of failing dilution checks when using quiklyte dilution check lot 4md707. this lot may exhibit a positive bias possibly beyond 5% that can result in a dilution check failure or may result in an unnecessary correction if the bias is between 1 - 5%. a dilution check failure prevents complete installation of the quiklyte integrated multisensor as described in the dimension operator's guide.