Events

Recall of Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device

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-2018-RN-00101-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00101-1
  • 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 anti-tsh-r well carriers 14-5639-01 in lot 0014 has been discovered. the specified lot includes a limited number of carriers, where 8 or 16 wells in sequence will produce decreased response units (ru). out of 4122 carriers, to date 12 carriers have been identified giving this low ru pattern.To date, no adverse events have been reported. in australia these kits are currently used for evaluation purposes, not for generating patient results.This recall does not affect any other lots of elia anti-tsh-r or any other phadia products.
  • Action
    Abacus ALS is advising affected users to quarantine any affected stock of the specified lot and discontinue use.

Device

Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
  • Model / Serial
    Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical DeviceLot Number: 0014.Abacus ALS part number: PU14563901, Manufacturers part number: 14-5639-01ARTG Number: 229585 (Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd