Events

Field Safety Notices about VITROS® Chemistry 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 Ortho Clinical Diagnostics, Inc..

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, inc. (ortho) initiated this urgent field safety notice due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the systems listed above.  u90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros® chemistry products for immuno-rate assays (i.E., vitros® crbm, crp, dgxn, and phyt slides).  if a u90-382 or 6lu condition code (i.E., associated with a wash error) occurs, the condition code text located on the vitros® system and other user documentation indicates to dilute the sample. however, dilution may not be the appropriate action for all scenarios .

Device

VITROS® Chemistry System
  • Model / Serial
    VITROS® 250 Chemistry System 8132086 10758750004409 6801759 10758750001330 VITROS® 350 Chemistry System 6802153 10758750002054 VITROS® 5,1 FS Chemistry System 6801375 10758750001132 6801890 10758750001644 VITROS® 4600 Chemistry System 6802445 10758750012343 VITROS® 5600 Integrated System 6802413 10758750002740
  • Manufacturer
    Ortho Clinical Diagnostics, Inc.

Manufacturer

Ortho Clinical Diagnostics, Inc.