Events

Recall of Sorenson’s Buffer. 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 Thermo Fisher Scientific 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-2016-RN-00884-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00884-1
  • 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
    There are three deficiencies in the current labelling of sorenson’s buffer (ph 6.8 and 7.2). the labels are: 1) missing the dilution instructions, 2) have the incorrect spelling of sorenson’s and 3) do not clearly describe the product as concentrated. thermo fisher scientific has confirmed that the product, apart from the labelling, has not changed in any way. in the event of the product being used undiluted, there is minimal ph variation between the concentrated and diluted solutions (0.2 units) and consequently, no to minimal risk on performance. the corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.The corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.
  • Action
    Thermo Fisher Scientific is providing users with the correct labels and advising that the correct dilution factor is 1 in 10 diluted with deionised water.

Device

Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)Product Codes: FNNGG029 and FNNGG030Affected Lot Numbers: 1603216780, 1506195360, 1508200130, 1509202540, 1509203020 and 1510206300ARTG Number: 244172
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd