Events

Recall of BD CD8 Phycoerythrin (PE)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    17921
  • Event Initiated Date
    2014-12-24
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Reason
    It has been identified that the cd8 pe reagent has been contaminated with a low amount of cd4 fitc. it has been confirmed that the concentration of the cd8 antibody in the oe conjugate is sufficient to detect cd8 antigen on the targeted cells however the presence of cd4 could result in the possibility of an unexpected staining pattern., the concern with the above issue is that the cd4 cells will be expressed along the fitc axis. any marker that is stained on the fitc axis will contain this incorrectly stained cd4 population. subsequent downgating will make the data appear as if the cd4 population is not present.
  • Action
    Product to be exchanged

Device

BD CD8 Phycoerythrin (PE)

Manufacturer

manufacturer #1479