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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Importing error code mapping into instrument manager (im) v.8.12.10 and higher may clear another configuration's error code mapping. results that should be flagged from that configuration will not be flagged and have no result error codes. rules that evaluate error code(s) may also be affected. per data innovations: the absence of result flags and error codes compromises result evaluation and handling. medical decisions based on these potentially erroneous results can lead to patient harm.
Model Catalog: VX.XX (Lot serial: software-no lot numbers); Model Catalog: 8.14.01 (Lot serial: software-no lot numbers); Model Catalog: 8.14.00 (Lot serial: software-no lot numbers); Model Catalog: 8.13.04 (Lot serial: software-no lot numbers); Model Catalog: 8.13.03 (Lot serial: software-no lot numbers); Model Catalog: 8.13.02 (Lot serial: software-no lot numbers); Model Catalog: 8.13.01 (Lot serial: software-no lot numbers); Model Catalog: 8.13.00 (Lot serial: software-no lot numbers); Model Catalog: 8.12.22 (Lot serial: software-no lot numbers); Model Catalog: 8.12.21 (Lot serial: software-no lot numbers); Model Catalog: 8.12.20 (Lot serial: software-no lot numbers); Model Catalog: 8.12.12 (Lot serial: software-no lot numbers); Model Catalog: 8.12.11 (Lot serial: software-no lot numbers); Model Catalog: 8.12.10 (Lot serial: software-no lot numbers); Model Catalog: VX.XX (Lot serial: N/A); Model Catalog: 8.14.01 (Lot serial: N/A); Model Catalog: 8.14.00 (Lot serial: N/A); Model Catalog: 8.13.04 (Lot seria