Events

Recall of Elecsys CMV IgM assay (04784618190) - Diluent Universal. 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-2015-RN-00120-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00120-1
  • 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
    Internal investigation results by roche diagnostics confirmed that certain lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with two lots of the elecsys cmv igm assay. roche confirmed that a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one of the three specific antigens included in the cmv igm assay. the signal reduction has only minor effects on the calibrators and controls (precicontrol cmv igm) and therefore is likely to remain undetected, resulting in false non-reactive cmv igm results and undetected acute cmv infections. in summary, there is a reasonable probability that the use of affected diluent lots may lead to delayed or incorrect diagnosis and/or treatment of acute cmv infection.
  • Action
    Roche Diagnostics is requesting the customers to discard all current stocks of affected Diluent Universal and replace with the Diluent Universal (11732277122 - LOT 181121) that has been shipped to the laboratories free of charge. Roche Diagnostics is further requesting laboratories to review the Negative Elecsys CMV IgM patient samples tested between 1st November 2014 and receipt of this notice, whose results fell within the COI range of 0.5-0.7 COI and were obtained using one of the Diluent Universal lots and recommending appropriate patient re-testing with the new diluent lot provided. This action has been closed-out on 17/08/2016.

Device

Elecsys CMV IgM assay (04784618190) - Diluent Universal. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Elecsys CMV IgM assay (04784618190) - Diluent Universal. An in vitro diagnostic medical device (IVD)Lot Numbers: 03183971122 and 11732277122Supplied since 1st November 2014
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited