Health Canada — Medical Devices · Canada · 2016-04-04 · Type III
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Reported risk: Siemens has identified that software version 1.4.2133 does not trigger the following flags: - the W warning flag for detecting small sample volumes when using the international software configuration. If there is not enough sample volume of the patient's blood when the sample is run, results may be lower than expected. This can occur if the required sample volume as defined in the ADVIA 560 Hematology System operator's guide is not followed. - the G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (AtLP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in the ADVIA 560 Hematology System operator's guide, the immature granulocytes and atypical lymphocyte morphology flags should be raised when the presence of morphologically abnormal cells is suspected indicating that a manual count on a stained smear needs to be performed.
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