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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Manufacturer has identified through customers complaints a possibility that the elecsys hiv combi pt may show a calibration signal shift in the control pc hiv level 1 and may read out of range (>3sd).
Model Catalog: 05390095190 (Lot serial: lot #175019); Model Catalog: 05390095190 (Lot serial: lot #173326); Model Catalog: 05390095190 (Lot serial: lot #172659); Model Catalog: 05390095190 (Lot serial: lot #171983)