Events

Recall of Elecsys HIV combi PT assay. 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 Roche Diagnostics Australia Pty Limited.

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-00030-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00030-1
  • 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
    Recent cases have been reported of a calibration signal shift regarding the elecsys hiv combi pt assay (gmmi kit: 05390095-190) on modular analytics e170, cobas e 601 and e 602 analysers.The reagent packs reporting a calibration signal shift are affected during their use on the instrument. the affected on-board rack packs are identified by the hiv control level 1 (pc hiv level 1) recovering out of range (>3sd) during use.
  • Action
    Roche Diagnostics is recommending that if users are affected to not re-calibrate the rack pack, discontinue use of the affected pack, record rack pack details of QC and Calibration signals and use a fresh rack-pack with new calibration and follow the instructions given in the package insert. Discarded kits will be replaced by Roche Diagnostics. Roche Diagnostics are continuing to investigate the cause of the issue and will advise users when further information is available. This action has been closed-out on 29/01/2016.

Device

Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)Lot numbers: 171983, 172659, 173326, 175019, 175493, 175494
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited