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 (ortho) has initiated this recall pertaining to the engen laboratory automation system configured with thermo scientific recapper module due to the possibility that the electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs the uncapped sample tubes may hit the cable and sample fluid (e.G. serum) may splash from the tube and into another tube or onto the under carriage of the support plate.