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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Beckman coulter has received customer reports of suppressed (i.E. no numerical values are produced) lact results for samples containing lact concentrations of 6.5 mmol/l or greater when using lot number m206209. beckman coulter has confirmed the issue for samples containing lact concentrations of 9.2 - 11.0 mmol/l. although these results are within the analytical range of 0.3 - 11.0 mmol/l (2.7 - 98.2 mg/dl) the results are suppressed and the system identifies the error condition rxn rate hi. numerical lact results produced without the rxn rate hi error conditions are accurate.