Health Canada — Medical Devices · Canada · 2019-04-29 · Type III
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Reported risk: Siemens healthcare diagnostics is informing customers regarding an issue on the Atellica CH 930 analyzers, which are installed with Atellica Solution Software (SW) versions v1.17 SP2 (SMN 11469659) and lower where a difference in results of greater than 10% has been observed between auto-diluted and manually diluted patient samples for results above the assay measuring interval on the Atellica CH 930 Analyzer. Samples within the measuring interval do not require dilution and are not impacted.
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