Events

Recall of VerifyNow Aspirin Test Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by In Vitro Technologies 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-2015-RN-01252-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01252-1
  • 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
    A limited number of kits may result in excessive sample leakage out of the test device cartridge. if this occurs, the verifynow performance results are not affected as the leakage occurs "downstream" of where the reaction occurs and operators are protected by the universal precautions for blood products; however, the instrument can potentially be affected.
  • Action
    In Vitro Technologies is advising users to inspect stock and quarantine affected batches for return and replacement with unaffected stock. In Vitro Technologies is advising users to perform a EQC test. This action has been closed-out on 04/05/2017.

Device

VerifyNow Aspirin Test Kit
  • Model / Serial
    VerifyNow Aspirin Test KitItem Number: ACD85053Lot Number : WH0204ARTG Number: 215577 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd