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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Ostase calibrator and qc vials have been observed to have an increased rate of breakage when stored at -70oc and thawed prior to kitting and shipment to the customer. the cracked calibrator and qc vials break and leak reagent in the kit box during shipment to customers.