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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Due to a design defect the 3-way valves may fail allowing cleaning solution which contains bleach to leach into the analytical lines and cause erroneous results.
Model Catalog: 04911855 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 09066916 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 078-A010-07 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 078-A001-14 (Lot serial: ALL SERIAL NUMBERS)