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 determined that specific access ostase calibrator and qc lots do not meet their expiration date claims within our 10% criteria. for these lots we determined that ref b83876 and b83877 have 68 days of stability and ref 37305 and 37309 have 51 days of stability. access ostase calibrator and qc instability could result in falsely elevated patient results or qc failures. for 37305/37309 the instability could cause patient results to be overestimated by as much as 16% at the original expiration dates. for b83876/b83877 the instability could cause patient results to be overestimated by as much as 16% as of october 17 2016.