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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A prepstain system rack setting was incorrectly entered (during a routine preventive maintenance visit) resulting in a tube position with the wrong y offset for rack four only. specifically the y offset had the 12th position mapped to an incorrect tube. the error consisted of a single patient sample being drawn and deposited on four (4) consecutive slides: - patient specimen from tube 1 was deposited on slides 1-4. - patient specimen from tube 5 was deposited on slides 5-8. - patient specimen from tube 9 was deposited on slides 9-12. the error was introduced due to an incorrect keystroke by the bd field service engineer (fse) (human error). the incorrect rack setting led to: - patient samples which were not tested during a test run (specifically each run of 48 patient samples would include 9 patient samples that were not processed) and - incorrect reporting of patient results. the 9 patient test results (not tested) were reported from the other patient specimens.