Events

Recall of VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs 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-2014-RN-00820-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00820-1
  • 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) received complaints of results for patient and proficiency samples were elevated in some instances. proficiency sample results when using vitros ca 19-9 kit lot 1320, compared to previous kit lots used and analysed (ocd internal testing), found an overall average positive bias of approximately +30% for samples within the normal range (<=37 u/ml) and +17% for samples above the normal range (>37 u/ml).
  • Action
    Laboratories are being advised to immediately discontinue using and discard all remaining inventory of VITROS CA19-9 Calibrators and Reagent Packs, Lot 1320. Review previously reported results using VITROS CA 19-9 Reagent Packs, Lot 1320 and discuss any concerns regarding previously reported results with your Laboratory Medical Director or the requesting physician to determine the appropriate course of action. Ortho-Clinical Diagnostics (OCD) will provide credits/replace stock of any product affected by this recall. This action has been closed-out on 12/08/2016.

Device

VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic med...
  • Model / Serial
    VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic medical device (IVD)VITROS Immunodiagnostic Products CA 19-9 CalibratorsProduct Code: 6800035VITROS Immunodiagnostic Products CA 19-9 Reagent PackProduct Code: 6800040Lot Number: 1320Expiry Date: 12 September 2014
  • Product Classification
    Immunology and Microbiology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics