Events

Safety Alert for Unicel DxH 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
    2015-12-07
  • Event Date Posted
    2015-12-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151207b.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 cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning unicel dxh 800, dxh slidemaker stainer (sms) and dxh 600 cellular analysis systems. the affected products are identified as follows: dxh 800: reference number: 629029, b24465, b24802; software version: 3.0.2.0 dxh sms: reference number: 775222; software version: 3.0.2.0 dxh 600: reference number: b23858; software version: 1.1.1.0 the manufacturer has determined that the software for the affected dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission. according to the manufacturer, the issue creates the potential for sample misidentification and possibility of releasing erroneous results. the manufacturer is advising customers not to edit the specimen id for a pending test order at the system manager’s worklist – pending or worklist – review tabs. 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 december 2015.

Device

Unicel DxH Cellular Analysis Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter Unicel DxH Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter