Events

Safety Alert for UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems

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
    2016-05-09
  • Event Date Posted
    2016-05-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160509.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 unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems. the affected products are identified as follows: unicel dxh 800 coulter cellular analysis system reference.: 629029, b24465, b24802, b68304 software version: 2.0.0.0 and greater unicel dxh 600 coulter cellular analysis system reference: b23858 software version: 1.0.0.0 and greater the manufacturer has identified an issue where the rbc aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures, flagged results and vote outs for rbc and plt parameters. affected users are instructed to: address any daily checks system alarms and background failures as indicated in the online help or instructions for use (part number b26647ac and b16421ad); and monitor flags on patient and control results according to their laboratory protocols. according to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2016.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter