Health Canada — Medical Devices · Canada · 2017-08-15 · Type III
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Reported risk: Periodically fail sample processing due to E18-excessive sample volume errors. Root cause has been attributed to no x-axis holding force during the pipettor homing routine which can cause incorrect homing of the pipettor z-axis. Software anomaly which, in rare cases, can impact the tomcat's pipettor arm, causing the sample pipette tip position to offset slightly lower than normal.
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