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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A technical investigation has confirmed that pathodx strep b latex may produce weak or slow reactions that may result in a failure to identify b-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
Model Catalog: R62025 (Lot serial: LOT 1470133); Model Catalog: R62031 (Lot serial: LOT 1463129); Model Catalog: R62025 (Lot serial: LOT 1463129); Model Catalog: R62031 (Lot serial: LOT 1470133)