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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Following a production change of connector types for the sample probe plug it was confirmed by the manufacturer that in very rare cases a disturbance of the sample liquid level detection (lld) may occur. this may cause the affected sample probe to dip into the sample material deeper than intended causing the affected sample probe to be washed inadequately and lead to a potential carryover.
Model Catalog: 04826876001 (Lot serial: 16F9-20); Model Catalog: 04826876001 (Lot serial: 16F9-10 to 16F9-18); Model Catalog: 04826876001 (Lot serial: 15D0-01 to 16D8-20); Model Catalog: 04826876001 (Lot serial: 16D9-02 to 16E0-10); Model Catalog: 06473245001 (Lot serial: 15F6-07 to 17M8-10); Model Catalog: 04826876001 (Lot serial: 16E0-16 to 16F9-08); Model Catalog: 04745914001 (Lot serial: 15P1-01 to 16Y4-19); Model Catalog: 04745914001 (Lot serial: 16Y5-01 to 17Z3-20); Model Catalog: 05641489001 (Lot serial: 15E6-01 to 17H7-10); Model Catalog: 05964075001 (Lot serial: 17L9-10); Model Catalog: 05964067001 (Lot serial: 15A6-01 to 16D9-10); Model Catalog: 05964075001 (Lot serial: 15D5-01 to 17L8-10); Model Catalog: 05964075001 (Lot serial: 17L9-09)