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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This medical device recall is to communicate the release of a washer firmware update 04.0019 on the galileo neo. this firmware update is intended to reduce the occurrence of false errors with the washer liquid level sense (lls) function during initialization or assay processing on the neo. the lls function checks for inadequate volume before and after each assay wash. this firmware update will be applied to neo systems currently operating with instrument control software (ics) 1.5.10.7. immucor has determined that unexpected (false) lls errors are linked to the presence of excessive salt accumulation.