Events

Recall of Beckman Coulter Access Free T3 reagent

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

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
    20295
  • Event Initiated Date
    2016-06-21
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    Specific lots manufactured post june 2015 of the access free t3 reagent demonstrate an upward shift in patient results., patient sample results will shift upward by approximately 10.4% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change., additional assay performance characteristics are not affected., due to matrix differences, qc values may not demonstrate a shift.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckman Coulter Access Free T3 reagent
  • Model / Serial
    Model: A13422, Affected: Lot Nos: multiple (all lots manufactured post June 2015)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc