Events

Recall of Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. 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 Shanahan Consulting 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-2012-RN-00789-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00789-3
  • 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
    Anomalous decreases in the average optical density (od) have been observed with certain kits within the lifecodes pak product line. the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
  • Action
    Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is required.

Device

Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medi...
  • Model / Serial
    Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medical device (IVD)Substrate buffer Lot Number: SB092011used with:LIFECODES PAK12Catalog Number: PAK12Kit Lot Number: 101911P12LIFECODES PF4IgG KitsCatalog Number: HAT45GKit Lot Number: 100311H45G
  • Manufacturer
    Shanahan Consulting Pty Ltd

Manufacturer

Shanahan Consulting Pty Ltd
  • Source
    DHTGA