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 internal product review determined that there was an issue with software versions 2.60/2.4.0.0 and 2.61/2.4.1.0 for the clinitek status+ connect systems which could potentially affect patient results. in the case that an operator transmits all of the data stored in the instrument to an lis or data manager by selecting the "send all" function the software will allow the operator to perform a urinalysis strip or cassette test while data is still being transferred. in this case the instrument may be slow to respond. depending on the amount of data being transferred and the speed at which it is transferred there may be a delay in timing when the urinalysis reagents are read by the analyzer. this delay in read time may potentially affect patient results.