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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Sysmex america inc. (sai) has become aware through customer complaints that the computer power supply on the information processing unit (ipu) used with the sysmex xn-series xt-series and xs-series hematology analyzers shut down disabling the analyzer. the power supply has an over-voltage regulator to halt power in the presence of a power spike and prevent potential damage to the power supply and the associated device. the regulator in the power supplies within a specific serial number range were found to be more sensitive than necessary to normal power fluctuations causing the shutdown of the ipu during normal operation.