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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When problematic lots of system rinse are used with the quanta flash mpo reagents (cat.# 701133) the system is not able to successfully complete calibration and the message "average rlu outside calibration range - 50% - 50%" is displayed. the bioflash cannot proceed to perform a mpo test.