Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its AU480 Chemistry Analyzer [Software Version 1.81].
A software defect has been identified on newly installed AU480 systems with software version 1.81. The defect may generate incorrect test results for 2 step method assays on AU480 systems configured with closed channels. New AU480 systems configured to allow for full open channels are not affected.
The software defect occurs when Edit and then Confirm are pressed on the Specific Test Parameters screen of closed channels. The result is the Measuring Point-2 settings will be deleted. The Measuring Point 2 settings are used for sample blank adjustments for 2 step methods. For samples which may have LIH (Lipemia, Icterus, Hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 September 2015