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 determined through an internal investigation that the assays listed do not align with the representative data published in the instructions for use (ifu) for onboard stability calibration frequency and/or interference. the assays that did not meet the obs and the calibration frequency ifu claims are: microalbumin_2 (ualb_2) alanine aminotransferase (altp5p) lithium (lith) alkaline phosphatase (alpamp) alkaline phosphatase (alpdea) magnesium (mg) magnesium concentrated (mg_c) total protein ii (tp) acetaminophen (acet) immunoglobulin g_2 (igg_2) transferrin (trf) total bilirubin (added to customer notification due to typographical error). the assays that did not meet the interference ifu claims are: alanine aminotransferase (alt) ammonia (amm) carbon dioxide liquid (co2_l) gamma-glutamyl transferase (ggt) high sensitivity c-reactive protein (hscrp) inorganic phosphorus (ip) inorganic phosphorus_concentrated (ip_c) lactate (lac) uric acid_concentrated (ua_c) wide range crp (wrcrp) lithium (lith) alkaline phosphatase (alpamp).