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 has confirmed that the presence of dhea-s (a metabolite of dhea a steroid hormone that may be used as part of in vitro fertilization (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results on the advia centaur dimension vista and immulite systems around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. this threshold is used by some ivf protocols to determine whether to proceed with fresh embryo transfer in the current cycle.
Model Catalog: 126345 (Lot serial: ALL LOTS); Model Catalog: 125362 (Lot serial: ALL LOTS); Model Catalog: 01586287 (Lot serial: ALL LOTS); Model Catalog: 118530 (Lot serial: ALL LOTS); Model Catalog: 02382928 (Lot serial: ALL LOTS)