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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Ocd determined that extension springs on some vitros systems may be out of the manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in our manufacturing facility it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. our evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. to date ocd has not received any customer complaints related to this issue.