Events

Field Safety Notices about Yumizen H500 CT (Closed Tube)

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 HORIBA ABX SAS.

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
    2017-06-20
  • 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
    Product development activities have shown that a defective positioning of the sampling needle could, in some instances, lead to the wearing of the rinsing header ring of the needle. this technical issue could generate an over estimation of platelets counting. this background is usually detected when a blank cycle is performed at the instrument start up (failed start up alarm). however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelets counting.

Device

Yumizen H500 CT (Closed Tube)

Manufacturer

HORIBA ABX SAS