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 some access free t3 reagent packs (p/n a13422) of lot 431433 were filled incorrectly. these packs contained insufficient quantity of reagents in one or more of the pack wells. affected reagent packs have the potential to generate incorrect control and patient results dependant upon the instrument and software version installed at the time the reagent lot was in use.