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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The centrifuge chamber carriers have been found to be out of specification tolerance limits which could lead to increased difficulty to load chambers into the machine.
Model Catalog: 4R5707 (Lot serial: IN THE TECHNICAL SERVICE); Model Catalog: 4R5707 (Lot serial: ALL SERIAL NUMBERS NOT LISTED); Model Catalog: 4R5707 (Lot serial: BULLETIN TSB-1270-013.)