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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The acl top instrument may generate an atypical bimodal clot curve without a warning or error. this occurrence of bimodal curves leads to erroneous results where a shorter than expected result is generated by the instrument.
Model Catalog: 0000280040 (Lot serial: 08010100 to 10061231); Model Catalog: 0000280020 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280000 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280030 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280000 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280020 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280030 (Lot serial: 06020101 to 10030659); Model Catalog: 0000280030 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280020 (Lot serial: 06020101 to 10030659); Model Catalog: 0000280000 (Lot serial: 06020101 to 10030659)