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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It was recently identified that some vysis paraffin pretreatment reagent kits may have been distributed with an incorrect lot number printed on the packaging labeling. the kit lot number appears in three places on the vysis paraffin pretreatment reagent kits: 1. the abbott molecular certificate of analysis that is packed within each kit 2. the label which is placed on the kit carton and 3. the label which is placed on the outer sleeve that goes over the kit carton. the correct lot number is 2087c172 and it is correctly printed on the certificate of analysis that is packaged within each kit. although unlikely an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.