Events

Recall of Dako EnVision FLEX/HPR reagent

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by DakoCytomation.

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
    19174
  • Event Initiated Date
    2015-09-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Global Science a Bio-Strategy Company (Bio-Strategy Limited), 241 Bush Road, Albany, Auckland 0632
  • 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 visualization reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualization 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., , 15/01/2016: subsequent to the earlier letter the remaining dako flex ready-to use antibodies were tested using the affected envision flex/hrp visualization reagent . two additional antibodies wereidentified as having a remote potential to affect results. update overview letter sent.
  • Action
    Product to be destroyed

Device

Dako EnVision FLEX/HPR reagent
  • Model / Serial
    Model: K8000 & K8012, Affected: 20019097 & 20020768
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation