Events

Recall of VITROS Chemistry Products HPT Reagent. 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-2012-RN-01143-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01143-1
  • 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
    Customers have reported the inability to calibrate vitros hpt reagent due to an increase in "u91-274" condition codes. in cases of successful calibration, some customers have also reported an increase in "u91-274" condition codes that prevented results when processing patient samples and quality control fluids. a potential for biased results exists if the user is able to obtain a valid calibration and quality control (qc) may not detect the issue.
  • Action
    Discontinue and discard remaining inventory of VITROS HPT Reagent. Ortho-Clinical Diagnostics recommends discussing previously reported results with the Laboratory Director to determine the appropriate course of action.

Device

VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)Product code: 6802214Lot number: 1533-19-2133 (Assay identifier 1533, GEN 19, Lot 2133); Expiration date: 20 Nov 2012Lot Number: 1533-20-2314 (Assay identifier 1533, GEN 20, Lot 2314); Expiration date: 11 Feb 2012
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics