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.
데이터 추가 비고
원인
Beckman coulter has determined that nonconforming sample probe cables may have been installed on newly manufactured and/or recently serviced unicel dxi instruments. use of a nonconforming sample probe cable can cause a delay in reporting results but will not cause erroneous results. a nonconforming sample probe cable may cause level sense errors. if a level sense error occurs due to a nonconforming cable the test may not start or an in-process test is automatically cancelled.