Events

Safety Alert for Automate 2550 and 1250, Aliquotter Tip Present Sensor

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
    2018-01-31
  • Event Date Posted
    2018-01-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180131b.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 2550 and 1250, aliquotter tip present sensor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2550 and 1250, aliquotter tip present sensor. the manufacturer has identified a rare potential issue with the tip present sensor within the robot of the aliquoter module. there has been one report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. according to the manufacturer, there is no impact to the sorter module associated with this issue. in the remote instance that a sensor is misaligned, and the system does not trigger the error message that a tip is not present, there is a remote chance of sample cross-contamination. as a precautionary measure, the manufacturer has instructed field service engineers to inspect the tip present sensor for misalignment at their next service visit. if the users suspect or observe unusual contamination of the tip carrier arm while performing daily maintenance, as described in the instructions for use, they are recommended to contact the local supplier and discontinue use of the aliquotter module. 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 31 january 2018.

Device

Automate 2550 and 1250, Aliquotter Tip Present Sensor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Automate 2550 and 1250, Aliquotter Tip Present Sensor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter