Events

Recall of Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ortho-Clinical Diagnostics Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01599-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01599-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics (ortho) has received an increase in customer complaints and has confirmed the intermittent presence of marked haemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation, and the root cause for the marked haemolysis, has been identified as microbial contamination. there is a single lot of one product affected in australia, reagent red blood cells 0.8% resolve panel c.If markedly haemolysed 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.
  • Action
    OCD is advising users to visually inspect all products prior to use and, as per the instructions for use, do not use red cell products if marked haemolysis or evidence of contamination is observed. If the product has marked haemolysis, contact Ortho Care Technical Solutions Center to report the issue so that the product can be replaced or credited. This action has been closed-out on 26/05/2017.

Device

Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).Product Code: 6902319Lot Number: VRC226Expiry: 3 January 2017ARTG Number: 254792
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd