Events

Recall of VITROS Immunodiagnostic Products HBsAg Controls. 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-00874-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00874-1
  • 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 have received customer complaints that the signal/cutoff (s/c) results have increased when using the negative control. their investigation confirmed that results generated using these lots of negative controls had a positive shift in mean results (s/c) as the product approached its open-reconstituted 5 day limit. increased results (s/c) may also be observed with the positive control.This issue is isolated to vitros hbsag controls. patient sample results generated using vitros immunodiagnostic products hbsag/hbsag es reagents are not affected.
  • Action
    Ortho Clinical Diagnostics is advising users to discontinue using and discard the affected lots. If you do not have an alternative unaffected lot, continue using the affected lot(s) following these instructions: - Control results must be within acceptable limits on the day of reconstitution (Day 1). - Store open-reconstituted vials frozen for up to 4 weeks. We recommend that you aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. - Upon receipt of replacement order, discard all remaining inventory. This action has been closed-out on 22/02/2017.

Device

VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).Product Code: 6800598Lot Numbers: 0860, 0870, 0880, 0890, 0908ARTG Number: 251956
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics