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 through internal testing that access ostase calibrator lots 528936 528938 and access ostase qc lots 528937 528939 do not meet their labelled expiration dates when stored after initial use (open vial stability). beckman coulter has determined that the above lots are stable at 2 to 10 degrees celcius for 58 days after initial use (i.E. after the vials are first opened). when stored unopened calibrators and quality controls are stable until the expiration date on the vials.