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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An anomaly with the aspiration or dispensing steps performed by the pump (particularly due to pump clogging) may impact the volume of patient sample pipetted or the other solutions transferred into the strip wells. as a volume decrease could induce an impact on the biological test result the quality control vidas (qcv) test has been designed to detect pump issues and alert the user before a biological test result is affected. qcv frequency and threshold alert have been defined to enable the system to detect progressive clogging.