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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Control product eightcheck 3wp xtra lot 3120 had an error on the pochi-100i assay barcode sheet for mean platelet volume (mpv) level 3 (l3). the barcode sheet had an incorrect mpv target value of 14.2 (correct value: 10.6). however the table of values on the assay sheet was correct with a value of 10.6 for mpv l3. all other assay values for lot 3120 were correct. the barcode discrepancy was reported to the technical assistance center which led to discovery of incorrrect bar code value for mpv l3 assay target. customer was preparing the poch-100i to use the new eightcheck 3wp xtra lot 3120 and noticed the discrepancy. the sai assay confimed the discrepancy and initiate orrective action.