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 3.1 and below. ocd determined that the software may not properly identify an expired calibration. calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. ocd's investigation confirmed that if the anomaly occurs a calibration may expire but the system may not alert the operator and not flag results with a ce sample result code (i.E. calibration expired). the system may unexpectedly generate results even though it is configured to not report results when a calibration has expired.