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 healthcare diagnostics has confirmed a carry-over risk on sysmex cs systems due to the following applications using ca-clean i (964-0631-3) for sample probe rinse: - protein c with protein c reagent (oqyg11) - protein s with ac reagent (opap03) - factor v leiden with proc global reagent (oqls13) under certain circumstances the carry-over might impact results for factor v with innovin factor xii with dade actin fsl berichrom f xiii innovance d-dimer assays. in case of innovance d-dimer only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.
Model Catalog: 10488586 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-2100I (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 10488584 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-2000I (Lot serial: ALL SERIAL NUMBERS); Model Catalog: CS-5100 (Lot serial: ALL SERIAL NUMBERS)