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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Beckman coulter is updating the prepplus operator's guide (pn 4237638da) and prepplus 2 instructions for use manual (pn 4277264ba) to modify the list of validated specimen tubes for use on the systems. we have determined that the specimen tubes being removed from the specimen tube list may not meet the "dead volume" (i.E. the amount of specimen that the system cannot access at the bottom of the tube) claim. if a specimen tube does not have sufficient dead volume the preparation of the specimen will not be compromised because the user will be alerted to the error through one or more error messages as indicated in the product labelling.