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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Ortho clinical diagnostics (ocd) has issued this recall due to a software anomaly that may potentially occur on vitros 4600 or 51 fs systems. ocd recently identified that under very specific conditions the temperature in the microwell subsystem (included on vitros 3600 and 5600 systems) may potentially be out of range without the system properly alerting the operator. although vitros 4600 and 51 fs systems do not include a microwell subsystem it utilizes the same software as vitros 3600 and 5600 systems. ocd has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the microslide or microtip subsystems included on vitros 4600 or 51 fs systems.