Events

Recall of EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Dako 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-00964-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00964-1
  • 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
    Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision flex/hrp visualisation reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualisation reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms’ tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining.
  • Action
    Dako is advising users to destroy any remaining lots of affected units. Dako is recommending that users re-evaluate test results from affected lots. This action has been closed-out on 25/08/2016.

Device

EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics...
  • Model / Serial
    EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)Multiple products affectedProduct Codes: K8000, K8002, K8023, K8010, K8012, K8024 and GV800Multiple Lot Numbers affectedARTG Number: 199416
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd