Events

Field Safety Notices about ABL800 FLEXQ

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 Radiometer.

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
  • 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
    In october 2017 radiometer informed about a potential issue with abl800 series analyzers. the issue was that in certain situations, the analyzer could misinterpret the barcode on the registration receipt received after placing a sampler in the flexq. this could potentially happen if the quality of the barcode is poor due to improper handling/damage or poor print quality. the end result could worst case be that the registration receipt was associated with a different sampler. .

Device

ABL800 FLEXQ

Manufacturer

Radiometer