Field Safety Notices about Reagent Red Blood Cell Products

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
  • Event Source
  • 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
    If markedly hemolyzed red cell products are used in testing, erroneous (false positive or false negative) results may be generated, which can potentially lead to patient harm. to date, ortho has received no reports of erroneous patient/donor results due to this issue. discuss any concerns you may have regarding previously reported results with your laboratory medical director to determine the appropriate course of action. as a reminder, the precaution section of the instructions for use for these products states: “do not use reagents if marked hemolysis or evidence of contamination is observed.” resolution corrective actions have been implemented and any rrbc product lots that expire after 2016-12-16 should not exhibit this hemolysis. .