Events

Recall of Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. 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-Strategy 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-2017-RN-00645-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00645-1
  • 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 manufacturer has recently identified an impurity (bacterial endotoxins) in the raw material used for the final formulation of the finished product of dynabeads hla class ii and dynabeads hla cell prep ii. their investigation determined that the presence of these endotoxins along with any deviation from the recommended cell isolation temperature in the user manual (e.G. performing some steps or storing product at room temperature) may reduce cell viability and lead to failure of the negative control.
  • Action
    Bio-Strategy are advising users to discontinue use of the affected material immediately, and to quarantine and place all unused product in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection, and will provide replacement product or issue credit..

Device

Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)Dynabeads HLA Class IICatalogue Number: 21003Lot Numbers: 00461955, 00477414, 00480193Catalogue Number: 21004DLot Numbers: 00461951, 00469604, 00477401, 00480209 Dynabeads HLA Cell Prep IICatalogue Number: 21903Lot Number: 00469606, 00477408, 00480204Catalogue Number: 21904Lot Numbers: 00455989, 00461965, 00469615, 00492942
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd