Events

Recall of BM Lactate Test Strips for use with the Accutrend Plus, Accutrend GC/GCT/Lactate. 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-2013-RN-00031-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00031-1
  • 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 bm-lactate test strips show a positive bias of 1.0 to 1.5 mmol/l with patient samples.
  • Action
    Roche Diagnostics Australia Pty Ltd is requesting that customers cease use and discard all lots of Accutrend BM-Lactate.

Device

BM Lactate Test Strips for use with the Accutrend Plus, Accutrend GC/GCT/Lactate. An in vitro dia...
  • Model / Serial
    BM Lactate Test Strips for use with the Accutrend Plus, Accutrend GC/GCT/Lactate. An in vitro diagnostic medical device (IVD)All lots (2133260x, 2153300x, 2173380x) within shelf life are affected Material Numbers: 3012654016 & 3012654370ARTG Number: 201876
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited