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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An internal investigation has shown that the use of the versatrek automated microbial detection system might result in false positive reports. to date three (3) customer complaints have been received all in conjunction with versatrek myco bottle usage. review of instrument databases suggests that on rare occasions the barometric pressure readings may be inconsistent. this event is caused by a protective sticker covering the sensor. if this sticker forms a complete seal it traps air under the sticker resulting in incorrect atmospheric pressure readings. this in turn leads to reports of false positives.