Events

Field Safety Notices about MULTIGENT Creatinine (Enzymatic) assay

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 Sentinel CH Spa.

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
    2017-05-22
  • 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
    Sentinel has detected a performance issue with the reagent 1 component of the three impacted lots listed above. this issue may result in quality control values shifting out of acceptable range, which is not resolved by recalibration. only replacement of the impacted lots with a new lot resolves the issue. in addition, some customers have reported erratic patient results. the investigation has determined that this issue is isolated to the 3 impacted lots listed above. the corrective and preventive actions already in place will avoid any future recurrence. .

Device

MULTIGENT Creatinine (Enzymatic) assay
  • Model / Serial
    lots 60335Y600, 60382Y600 and lot 60334Y600
  • Manufacturer
    Sentinel CH Spa

Manufacturer

Sentinel CH Spa