Events

Recall of Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD) With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests

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-01452-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01452-1
  • 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
    Erroneous results may occur as a result of a software issue with all versions of the phadia prime software up to and including version 2.1.4 connected to the phadia 250, phadia 2500e/ee and phadia 5000e/e+e instruments when running elia tests under specific scenarios as described below.The issue will cause the software to disregard default dilution factors for rejected samples, when using the “ok to all” function for retesting of samples if the following criteria are met: 1. more than one assay result are rejected within the same method -and- 2.The rejected results are run with tests which have different default dilution factorsif the two above scenarios occur at the same time, all samples will be retested with the dilution factor based upon the first rejected sample and assay dilution factor.
  • Action
    Abacus ALS is advising customers that this issue will be corrected through a mandatory update of the Phadia Prime software. A representative from Abacus ALS will be in contact with users as soon as the update is available. A copy of the customer letter should be retained in a prominent position until the update has been completed.

Device

Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD...
  • Model / Serial
    Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD)With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA testsARTG Number: 229542
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd