Events

Recall of chromID S.aureus agar (SAID/MRSA). 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 Biomerieux Australia Pty Ltd.

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-00804-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00804-1
  • 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
    During an internal investigation, biomérieux observed an anomaly on nine (9) lots of chromid s. aureus manufactured with the same semi-finished lot.This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result. biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed.
  • Action
    Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product. Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016.

Device

chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)chromID S.aureus agar (SAID)Lot Numbers: 1004119200, 1004044190, 1004085400chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170ARTG Number: 182081An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd