Events

Safety Alert for AutoMate 2500 Family

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
    2017-06-07
  • Event Date Posted
    2017-06-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170607b.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 automate 2500 family medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2500 family. the manufacturer has identified there is a potential that a component on the recapper module did not have the required coating specified for that part. the coating on the recapper component helps to both ensure the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. if there is an uncoated component on customer’s recapper, this could lead to tubes not being properly sealed. the manufacturer has determined that this situation would be highly unlikely to occur and the test results are not affected. the manufacturer will schedule a time to affected customer’s sites and confirm whether the proper coating on the recapper component is present, and replace the component if necessary. 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 7 june 2017.

Device

AutoMate 2500 Family
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter