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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The probe wash collar tubing of the sample aspiration module (sam) may become stretched or trapped during routine use of single-tube presentation station. when the tension on the tubing is severe the tubing may not be able to return to its home state and may pull the wash collar out of alignment with respect to the aspirate probe. the misalignment may result in incorrect seating of the probe wash collar and incomplete fluid collection during cleaning. excess fluid may be dripped across internal surfaces.