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 contained incorrect barcodes where the labels began with "43 02" rather than the required "43 01". these batches were placed on quality notification and dispositioned for rework to over-label the barcode area with the correct symbology. the over-label was manually applied to each tube. one customer complaint was received where the over-label had partially peeled off of the tube the incorrect barcode underneath was scanned into the mgit instrument and the epicenter connected to the customer's laboratory system incurred an error. the customer also noted that they found additional tubes in their shipment that had multiple labels or no over-label. the label prefix specifically the 3rd and 4th digits that indicate the media type gives the instrument information for what algorithm to apply for growth detection. growth detection testing will be performed by the mgit instrument every 60 minutes as usual on tubes containing incorrect barcode prefixes but will not flag as positive when growth is visible because media type "43 02" is not defined. a barcode overlabel peeling off exposing an incorrect barcode causes mgit false negative results by not flagging positive tubes. susceptibility tests are not affected since susceptibility testing is conducted in a carrier where instrument instruction is provided by the carrier.