Events

Safety Alert for AU480 Chemistry Analyzer

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Beckman Coulter.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-09-29
  • Event Date Posted
    2015-09-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150929c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: beckman coulter au480 chemistry analyzer 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.

Device

AU480 Chemistry Analyzer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter AU480 Chemistry Analyzer
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter