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.
데이터 추가 비고
원인
When the instrument temperature (<18c to <36.5c) is exceeded the dxh 500 allows sample processing and result reporting despite the instructions for use (table 10.4) stating that "the run sample is inaccessible". results generated in this scenario may be erroneous. additionally: the message on the results screen/printout reads "instrument temperature" instead of "instrument temperature out of range" the results are transmitted to the laboratory information system (lis) without the accompanying "instrument temperature out of range" message. using the auto-transmit option could lead to the release of erroneous results to the lis.