Events

Recall of VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty Diluent

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

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-2014-RN-00413-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00413-1
  • 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 inc confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. internal testing determined that results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor.
  • Action
    Ortho Clinical Diagnostics is requesting their customers to discontinue use and discard any remaining stock from the affected lots of diluent. Replacements from unaffected lots are available. This action has been closed-out on 11/04/2016

Device

VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS...
  • Model / Serial
    VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty DiluentProduct Code: 8559825Lot Number: F3168Expiry Date: 30 Sep 2014VITROS Chemistry Products FS Diluent Pack 3Product Code: 6801754Lot Number: 01-3266Expiry Date: 23 Sep 2014
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics