Health Canada — Medical Devices · Canada · 2020-01-24 · Type II
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Reported risk: Siemens Healthcare Diagnostics Inc. confirmed an average method comparison bias of up to 20% with ADVIA Centaur NT-proBNP (PBNP) Assay kit. Siemens' investigation verified that the ADVIA Centaur PBNP assay continues to meet the reference intervals listed in the ADVIA Centaur PBNP Instructions for Use (IFU) and concordance (agreement) to the predicate method is greater than or equal to 95%. Siemens is currently investigating root cause of the method comparison bias observed and will send a follow-up communication when further information is available.
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