Events

Field Safety Notices about Hematology analyzer for DxH 500 vials

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Beckman Coulter.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-11-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    - an internal investigation has uncovered. that 69 the bleaching cycle is stopped or interrupted, the dxh 500 analyzer will not display any warning and the system will not properly wash the remaining bleach before analyzing the sample. - if the bleaching cycle is interrupted, the subsequent restoration of the software to perform the diluent reset will not be sufficient to prevent a negative impact on the first sample analysis.

Device

Hematology analyzer for DxH 500 vials

Manufacturer

Beckman Coulter