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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Hologic has recently been notified by health canada regarding classification of the thinprep 2000 and thin prep 5000 processors. these products entered the canadian market as class i devices and it has been determined that these should be classified as class iii. this reclassification is the result of an administrative error and is completely unrelated to the safety and effectiveness of the thin prep processors. there are no issues or concerns with the safe and effective use of the thin prep 2000 or the thin prep 5000 processors and the integrity of all past current and future tests are not in question.
Model Catalog: 70031-001 (Lot serial: All lots); Model Catalog: 70031-002 (Lot serial: All lots); Model Catalog: 71362-001 (Lot serial: All lots); Model Catalog: 71362-002 (Lot serial: All lots)