Events

Recall of ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). 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 Abacus ALS 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-2016-RN-00978-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00978-1
  • 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
    Abacus are informing users regarding an issue regarding immunocap specific ige control h vial lot cyyac. precipitates have been identified in the affected vials and kit lots. if samples containing precipitates are used, an increased frequency of functional disturbances (error messages e.G. clot error etc.) is to be expected in the instruments. occurrence of precipitate in the control, such as in vial lot cyyac, could give an increased frequency of functional disturbances in the instruments. however, in-house studies undertaken by the manufacturer show no indication that the ige results would be affected by the precipitates.
  • Action
    Abacus is advising users to inspect stock and discard any remaining kits of the affected lots. Affected product will be replaced by unaffected lots. This action has been closed out on 13 Jun 2017

Device

ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro di...
  • Model / Serial
    ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD)Kit Article Number: 10-9530-01Kit Lot Numbers: JBWA, JEXGVial Lot Number: CYYACARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd