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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Have observed a very small number of packs that contained aberrant wells that produced a low signal and may cause a condition code (541-014) or an incorrect result.
Model Catalog: 6800731 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1940667 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1318450 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1062306 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 1515154 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1920115 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 192 5551 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1100387 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8577413 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8583130 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 813 6384 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800281 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800376 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 189 6836 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 6800377 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 8650939 (Lot serial: ALL LOTS BELOW 101); M