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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Observed and confirmed occurrences of out-of-specification volume transfers during prepmate operation. the syringes are not dispensing the minimum volume of 7.5 ml of the sample (specification: 7.5 - 8.5 ml). this may lead to an increase in unsatisfactory rates (< 5000 cells/slide) and ultimately a delay in diagnosis for the patient.