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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Iris international has confirmed the ichemvelocity automated urine chemistry system does not maintain the on-board strip stability of 5 days at 18-28 degrees c at 20-80% relative humidity (rh) as stated in the ichemvelocity product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the parameters defined in table 1 of the urgent medical device recall letter test results may be affected as indicated below: - false low or false negative results: ketone blood - false high or false positive results: bilirubin glucose leukocytes - false high results: urobilinogen ascorbic acid protein ph and nitrite are not affected.