Events

Recall of EliA Intrinsic Factor Well. 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 dx 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-2018-RN-00317-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00317-1
  • 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 malfunction of elia intrinsic factor well has been discovered in elia intrinsic factor well lot 0015. a customer complaint reported erroneous test results on one single carrier of elia intrinsic factor well (14-5668-01) lot 0015. internal investigation by phadia ab indicated that no antigen solution was dispensed during elia well coating for a part of the lot. the described problem could cause erroneous test results. an erroneous test result means that the reported value will be lower than the real value for the patient sample tested, causing false negative results.To date, there have been no reports of patient injury as a result of this issue. no other lots of elia intrinsic factor well are affected.
  • Action
    Abacus is advising customers to inspect stock immediately and quarantine any stock of Lot # 0015 to prevent further use. Customers should record the quantity in quarantine on the Customer Reply Form provided with the Customer Letter. Once the form is returned, Abacus will provide users with instructions to destroy or return the quarantined product.

Device

EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)Catalogue Number: PU14566801Lot number: 0015Expiry date: 31/01/2019ARTG: 229585Abacus dx - Clinical chemistry autoimmune IVDs
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd