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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The contact manufacturer informed diasorin inc. of the potential for the premature failure of certain cooling modules. the affected cooling modules were assembled incorrectly and as a result heat generated by the peltier (thermo-electric cooler) units of the cooling module may not be properly dissipated. the heat build up may shorten the expected lifespan of the cooling module. failure of the cooling module could cause the temperature in the liaison analyzer reagent area to exceed allowable limits.