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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Manufacturer has confirmed that dimension vista calcium (ca) flex reagent cartridge lot 16060bb may produce erroneously low results from specific well sets. this issue occurs infrequently affecting less than 1 per 350 wells (< 0.3%). if calibration is performed using an unaffected well set and samples are subsequently run using an affected well set ca results may be falsely depressed up to -2.9 mg/dl [-0.72 mmol/l]. if qc is run using an affected well set qc may detect the issue.