Events

Recall of VITROS Chemistry Products K+ Slides. 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.

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-2013-RN-01238-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01238-1
  • 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
    While performing an internal investigation, ortho clinical diagnostics (ocd) determined that the coatings of the vitros chemistry products k+ slides contain a surfactant that was unintentionally added during the manufacturing process. the affected slides continue to meet intended use and performance specifications, however the long term product performance is unknown.
  • Action
    OCD is requesting their customers to discontinue use and discard all units from the affected lots. Replacement kits will be provided if required.

Device

VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)Catalogue Number: 8157596Coatings: 0884, 0885
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics