Events

Safety Alert for DxH 500

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
    2016-03-09
  • Event Date Posted
    2016-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160309a.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 dxh 500 medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its dxh 500 (part number: b40601, software versions 1.0.0 and 1.0.1). the manufacturer is notifying users regarding an error in the result abnormal flags field transmitted from the dxh 500 to the laboratory information system (lis). test values are not affected. according to the manufacturer, the logic for the “a” code used in the result abnormal flags field is reversed for all test parameters. this letter does not apply if the user’s laboratory is not transmitting results to an lis or if the lis driver does not use the result abnormal flags field. the test results and flags generated by the instrument are correct and are not affected by this issue. the definitive messages, system messages, parameter flags and codes, reference intervals and action limit flags are displayed, printed and transmitted to the lis correctly. however, there is an additional flag, result abnormal flag, which is only transmitted to the lis that is incorrect. if the lis is using the result abnormal flags field, the lis may incorrectly interpret results. specifically, correct normal values may be erroneously flagged as abnormal and correct yet abnormal results may be missing the abnormal flag. this issue will be corrected in a future software release. 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 9 march 2016.

Device

DxH 500
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter DxH 500
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter