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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The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types and is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical industrial and research settings. the instrument has both "open system" and ivd functionality. there are two issues concerning the heater and the reader. these issues are being treated by health canada as separate recalls and therefore at the request of health canada a separate notice has been prepared for each. the heater is part of an assembly that controls thermal cycling during polymerase chain reaction (pcr) and opening of the wax valves in the consumable [pcr] cartridge. individual heaters may fail to reach target temperatures if a defect ("shunt") is present. the magnitude of the potential temperature error is as high as 10 c lower than expected however most estimates are near 2 c lower than normal (instrument spec is temperature +/- 2 c). there is the potential for false negative results.