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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Product is not supporting the growth of haemophilus influenzae atcc 10211and other haemophilus species. there is the possibility of a false negative result no growth haemophilus if it were present in a clinical sample. upon investigation the ph was above specification on 2 batches that fail to support growth of h. influenzae.