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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Siemens healthcare diagnostics has received customer complaints of discrepant siemens healthcare diagnostics has received customer complaints of discrepant patient results on dimension vista intelligent lab systems. siemens healthcarepatient results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed a software defect which in a very specific set of circumstances results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system. omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.