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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The stability at 2-8 degrees c after reconstitution in closed vials is reduced from 5 days to 2 days and stability on instruments reduced from 48 hours to 24 hours.
Model Catalog: OQWWII (Lot serial: 544454); Model Catalog: OQWWII (Lot serial: 544439 TO 544453); Model Catalog: OQWWII (Lot serial: 544455 TO 544458.)