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 coaguchek devices were designed with "error 6" serving as a fail-safe mechanism preventing inaccurate results caused by handing errors. however this "error 6" message might be displayed instead of the actual inr value. this problem might occur in patients with very long coagulation times i.E. high inrs such as those receiving treatment with vitamin k antagonists (i.E. warfarin) in combination with antibiotics and/or chemotherapeutics.
Model Catalog: 3666794 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 05448964001 (Lot serial: SN LESS THAN 6011000); Model Catalog: 04800842190 (Lot serial: SN LESS THAN 90000)