Events

Field Safety Notices about VITROS® Chemistry Products Na+ Slides

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 been made aware of the potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1½ to 8 hours then placed on the analyzer. ortho has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit. .

Device

VITROS® Chemistry Products Na+ Slides
  • Model / Serial
    VITROS Chemistry Products Na + Slides (10758750004812) 8379034 1 through 6 30 through 40 44 through 49 01-JAN-2017 through 01-JUN-2018 VITROS Na + Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/5,1 FS/4600/5600 Systems.
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics