Events

Recall of Abbott CELL-DYN Emerald Cleaner

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
    20125
  • Event Initiated Date
    2016-05-06
  • 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: Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, Auckland
  • Reason
    Previously identified occurrences where the cell-dyn emerald analyzer generates quality control (qc) out of range low for parameters rbc and plt when using emerald cleaner lots 6853, 6901, and 6953 (medsafe recall reference #19975 )further investigation identified additional lots 6991, 7024, and 7027 as having similar occurrences.
  • Action
    Product to be destroyed

Device

Abbott CELL-DYN Emerald Cleaner
  • Model / Serial
    Model: 09H46-02, Affected: 6991, 7024, 7027
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479