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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Ocd has received several reports of condition codes that occurred during the calibration of microwell assays. internal investigation determined that the microwell shuttle weight on some vitros systems may be uncoated and therefore out of our manufacturing specifications. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is not performed biased results could potentially occur. internal testing determined that quality control results using an uncoated well weight showed on average a 10% shift from established means that was within the quality control ranges. the magnitude of the bias is not likely to impact patient safety.