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 the navios flow cytometer instructions for use (ifu) states that when a drip chamber level warning occurs the instrument will acquire for at least 5 minutes longer after the drip chamber level warning message is displayed. however the system may only acquire for as little as 3 minutes after the drip chamber level warning and will provide drip chamber level error. at that time the instrument will abort acquisition and does not save the listmode file and data are lost.