Health Canada — Medical Devices · Canada · 2018-09-17 · Type III
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Reported risk: The DSX analyzer utilizes operating software Revelatlon. This software use set up as default with an algorithm for dealing with over/ under conversion. If an end user turns this off and they use the over limit in their Quality Control Equation the software will place 0.00 in the equation leading to an incorrect QC interpretation and potential incorrect value assigned to the result.
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