Events

Recall of ACL TOP Instruments

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Instrumentation Laboratory 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
    16822
  • Event Initiated Date
    2014-06-11
  • 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
    The manufacturer advises that under a particular set of circumstances there is the potential for a sample misidentification to occur.
  • Action
    Instructions for use to be updated

Device

ACL TOP Instruments
  • Model / Serial
    Model: Models: ACL Top, ACL Top CTS, ACL Top 700, ACL Top 700 CTS, ACL Top 700 LAS, ACL Top 500 CTS, ACL Top 300 CTS, Affected:
  • Manufacturer
    Instrumentation Laboratory Inc

Manufacturer

Instrumentation Laboratory Inc