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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Phadia ab (sweden) voluntarily recalls immunocap specific ige control (art.No 10-949-01) containing vial lot bnmax bnmay or bnmaz using immunocap allergen e1. manufacturer updates information on target range values for one of seven ranges stated in the directions for use. product is a control sample used by laboratory for internal quality assurance. a new range is established for immunocap allergen e1. for some customers the results may be out of range and could result in a quality assurance investigation at the customer's site.