Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its DxC 700 AU Clinical Chemistry Analyzer with software Version 1.07.

The manufacturer has identified an issue occurs with Software Version 1.07 when using the Quick Start or Related Manuals HELP screens. The issue may generate a white screen, hidden dialog box, or JavaScript error.

According to the manufacturer, when selecting some links in Quick Start or Related Manuals HELP screens, an Internet Explorer (IE) HELP window will open instead of an AU console HELP window and can lead to a hidden dialog box or white screen. If the user clicks anywhere else on the console without first closing the IE window, a white screen or hidden dialog box will occur and the system has to be rebooted. This could lead to a delay of reporting patient results. When selecting some links in HELP screens, a JavaScript error may occur. This can be closed with no delay in system function.

The affected users are advised to take the following actions:

• If they use the Quick Start or Related Manuals HELP screens, close the IE HELP window before clicking anywhere else on the console.
• If they do not close the IE HELP window and encounter an incorrectly displayed dialog box or a white screen, follow Steps 1 through 6 in the important product notice.
• If users use HELP screens and encounter a JavaScript error, close the dialog box by clicking the X button, Yes button, or No button.
• Use the HELP icon in the top Navigation Bar only when trying to access System Help. All HELP links can be used without issue with the exception of the four "Quick Start" and "Related Manuals" HELP links.

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 30 Nov 2018