Events

Recall of VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. 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-2016-RN-00648-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00648-1
  • 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
    The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using vitros afp reagent packs.Ortho clinical diagnostics (ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. the investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. there have been no reports of injuries as a result of this issue.
  • Action
    Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives. Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017.

Device

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medica...
  • Model / Serial
    VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)VITROS AFP Reagent PackDevice Identifier: 10758750006489Product Code: 1925551VITROS AFP CalibratorsDevice Identifier: 10758750006540Product Code: 1515154Lot Number: 1470Expiry Date: 13 Dec 2016ARTG Number: 248385
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics