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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The bd facs 7-color setup bead kit is shipped with a cd containing pass/fail values for the cytometer sensitivity test (part of cytometer qc). the incorrect version of the cd was included with bd facs 7-color setup beads (cat. no. 335775 lot no. 33412). the kit should have cd version 3.0 instead of 2.0. kit lot 33412 (part of "pl8" batches) was shipped with a cd containing pass/fail values for a different lot which was part of the "pl6" batches. the recall is specific only to the cd within the kit. the 7-color setup beads are not affected. bd is not requesting that the 7-color setup beads be destroyed.