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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Radiometer has recently become aware that the valve tubing 841-797 for the abl90 flex analyzer may potentially leak at the steel tube connector in the hemolyzer unit. this may result in droplets of fluid dripping onto the plate underneath the valve or onto the bottom of the oxi module housing.