Recall of Beckman Coulter HemosIL SynthASil APTT Reagent on ACL TOP Family

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
    15051
  • Event Initiated Date
    2013-07-29
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    Potential carryover issue identified on the acl top family that causes shortened aptt results.The carryover is introduced during the liquid height check that is performed upon rack insertion, and the sequence in which the assays are performed.
  • Action
    Software to be upgraded

Device

  • Model / Serial
    Model: ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTS, Affected: All in-date lots
  • Manufacturer

Manufacturer