Events

Recall of Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zoll Medical Australia Pty Ltd.

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
    RC-2013-RN-01364-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01364-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, itc has determined that citrate aptt cuvettes from the lots listed above may recover higher than expected results in normal individuals. itc’s investigation into the affected lots identified that when performing tests on non-heparinized e.G., normal blood samples, results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected. itc has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated aptt baseline may contribute to serious injury.
  • Action
    Zoll Medical Australia is requesting their customers to inspect their stock and quarantine all affected lots of the product. Zoll Medical Australia will arrange for the recovery and replacement of stock. Customers are advised that the requirement for retesting reported patient results should be discussed with the Laboratory Director.

Device

Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical dev...

Manufacturer

Zoll Medical Australia Pty Ltd