Events

Recall of MRSASelect II agar. 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 Bio-Rad Laboratories 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-2018-RN-00703-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00703-1
  • 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
    Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
  • Action
    Bio-Rad is advising: - For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step. - Do not use a suspicious colour agar. - As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.

Device

MRSASelect II agar. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    MRSASelect II agar. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 63757 & 63759Multiple Lot NumbersARTG Number. 188609(Bio-Rad Laboratories - Microbiological culture media IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd