Events

Field Safety Notices about VITROS® Immunodiagnostic Products Total β-hCG II 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) has confirmed that when testing was conducted using the lots listed above, vitros® systems generated results within the measuring range for samples known to not contain measurable hcg. customers reported that their vitros® system reported results up to approximately 7.40 miu/ml (iu/l) for patient samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)). our records indicate that you were shipped an affected lot of this product. .

Device

VITROS® Immunodiagnostic Products Total β-hCG II Reagent Packs
  • Model / Serial
    1410 (17-Jun-2016) 1420 (17-Jun-2016) 1430 (17-Jun-2016) 1440 (15-Aug-2016) 1450 (17-Aug-2016) 1460 (17-Aug-2016) 1470 (17-Aug-2016)
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics