Events

Field Safety Notices about VITROS® Immunodiagnostic Products Intact PTH Reagent Packs

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 Ortho Clinical Diagnostics.

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
    As part of a field safety corrective action, ortho clinical diagnostics (ortho) initiated this urgent field safety notice having confirmed that results obtained from vitros ipth reagent packs are positively biased (i.E., falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs in comparison to the roche elecsys pth test. our data demonstrated that this bias was consistent for all in-date lots. method comparison data are located on page two. .

Device

VITROS® Immunodiagnostic Products Intact PTH Reagent Packs

Manufacturer

Ortho Clinical Diagnostics