Events

Recall of ImmunoCAP Allergen f205, Herring. 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-2017-RN-00912-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-08-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00912-1
  • 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 als is advising that immunocap allergen f205, herring, lot 999g5 contains the wrong allergen. this could cause erroneous test results, which may cause a delay in a proper diagnosis, however, the probability of a serious adverse health consequence or serious deterioration in state of health due to a delayed diagnosis is estimated to be negligible.
  • Action
    Actions to be taken by the customer/user: 1. Stop using the affected lots; 2. Discard any unused product; 3. Retest any samples that have been tested using the affected product; and 4. Fill in the Medical Device Recall return response form supplied with the customer letter and return to Abacus ALS.

Device

ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)Product Number: 14-4837-01Lot Number: 999G5ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd