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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Ortho clinical diagnostics (ocd) has identified an anomaly with vitros system software version 3.0 and below. internal testing confirmed that when using calibrator barcode labels supplied with vitros chemistry products calibrator kits 1 2 3 4 6 or 9 an unexpected assay calibration may occur if assay targets are unassigned. consignees are being instructed not to use the calibrator barcode labels for vitros calibrator kits 1 2 3 4 6 or 9 until the next version of software is installed on their vitros system.