Events

Field Safety Notices about Tissue Processor

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 Leica Biosystems Nussloch GmbH.

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
    2015-07-29
  • 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
    The asp6025 is sporadically and incorrectly getting into the wrong instrument state “bottle empty" during retort ng, after passing f' level sensor 2 and prior to reaching level sensor 3, thus prior to completing the 5 litre filling. this potentially leads to suboptimal quality of processed tissue. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.

Device

Tissue Processor

Manufacturer

Leica Biosystems Nussloch GmbH