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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Integra lifesciences initiated a recall to remove all affected licox probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. the ikn2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated po2 values (from -1 mmhg to -7 mmhg) when the probes are used.
Model Catalog: CC1.P1 (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: CC1.SB (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP1.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IP2.P (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.ST (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM1.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IM3.S (Lot serial: ALL LOT #'S SINCE OCT 1 2013); Model Catalog: IT2 (Lot serial: ALL LOT #'S SINCE OCT 1 2013)