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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Meridian has discovered that the sample preparation apparatus iv is susceptible to evaporation over the shelf life causing low volume of the liquid reagent. post market studies indicate that this component may not be stable through the labeled expiration dating due to this evaporation. internal testing has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.