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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Beckman coulter has determined that additional clarification for the blast suspect messages is necessary. in rare situations the unicel dxh 800 and dxh 600 coulter cellular analysis system may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as sample limitations.
Model Catalog: B24802 (Lot serial: all lot numbers contact MFG); Model Catalog: 629029 (Lot serial: all lot numbers contact MFG); Model Catalog: B23858 (Lot serial: All lot numbers contact MFG)