Events

Recall of VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). 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-01099-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01099-1
  • 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 (ocd) has conformed that positively biased serum or plasma sample results may occur by up to +1.5mmol/l.
  • Action
    OCD will replace your remaining inventory for VITROS® Na+ Slides calibrated with Lots 212 and 292. It is acceptable to use Lot 212 or 292 to calibrate VITROS® CHOL, Cl-, ECO2, and TRIG Slides until your replacement product arrives. This action has been closed-out on 01/02/2016.

Device

VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 C...
  • Model / Serial
    VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). An in vitro diagnostic medical device (IVD)VITROS Chemistry Products Na+ SlidesProduct Code: 8379034Lot Numbers: GENs 7 to 13Expiry Dates: 01/11/2013 to 01/01/2015VITROS Chemistry Products Calibrator Kit 2Product Code: 1662659Lot Numbers: 212, 292Expiry Dates: 31/08/2014, 28/02/2014
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics