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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Meridian has received reports from customers that false positive test results have been obtained with some broth samples using lots 608096h219 608096h222 608096h225 and 608096h226. false positive complaints have been neither reported nor confirmed on direct stool specimens. the rate of false-positive results will vary from laboratory to laboratory and may be dependent on the laboratory's test volume. kit lots 608096h222 608096h224 and 608096h226 were not distributed in canada .