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 is issuing a customer notification for advia centaur t4 assay for the manual 1:4 and 1:8 dilution recovery used on advia centaur and advia centaur cp systems. percent recoveries for 1:4 (with calibrator 'a' prior to lots ending in 87) and 1:8 (all lots) patient sample dilutions are lower than reported in the ifu. a similar shift between calibrator 'a' and the internal standardization for t3 assay was also identified.
Model Catalog: 04848169 (Lot serial: 43789); Model Catalog: 04779779 (Lot serial: 43789); Model Catalog: 04779663 (Lot serial: 43789); Model Catalog: 04779671 (Lot serial: 43789); Model Catalog: 04848169 (Lot serial: 38453); Model Catalog: 04779779 (Lot serial: 38453); Model Catalog: 04779663 (Lot serial: 38453); Model Catalog: 04779671 (Lot serial: 38453); Model Catalog: 04848169 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 04779779 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 04779663 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 04779671 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 04800735 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 04800646 (Lot serial: ALL UNEXPIRED LOTS); Model Catalog: 110735 (Lot serial: ALL UNEXPIRED LOTS)