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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Reason for the recall: instit kits that contain blotted membrane units from lot number b1a128 may produce false positive results with the instit negative control or with a patient's sample. three lots of instit were manufactured with the affected membrane units from lot b1a128: b1a135 b1a136 b1a137.