Events

Field Safety Notices about Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System

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 Siemens Healthcare Diagnostics Products 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
    2015-06-15
  • 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
    We have observed that in single cases the absorbance value obtained for the enzygnost® anti-hcv 4.0 control, positive on bep 2000 / bep 2000 advance system can be found lower than expected. the occurrence of this issue is triggered by an instrument liquid handling step (conjugate pipetting) in conjunction with enzygnost anti-hcv 4.0. as a precautionary measure we would like to inform you that an enhanced liquid parameter setting is now available for the enzygnost anti-hcv 4.0 method on bep 2000 / bep 2000 advance system. this enhanced setting has been verified internally and leads to a more robust assay performance. there is no change in the assay format, only a minor adjustment of the liquid parameter setting for the enzygnost anti-hcv 4.0 conjugate transfer step. .

Device

Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS