Events

Recall of RE51021 / MuSK-Ab ELISA

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-01435-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01435-1
  • 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
    This notice is to inform you about a recall action for ibl international product ibre51021 musk-ab elisa lot emu124 with expiry date 31-10-2018. this action has been undertaken by the australian distributor abacus als following consultation with the therapeutic goods administration (tga). no other lot numbers of this product are affected by this recall. description of the problem: the user of this assay may notice that the antiserum (#kemu521, lot: s882) and assay buffer (#kemu751, lot: s881) appears contaminated (cloudy and contain particles). this issue is caused by a contamination of lot # emu124.
  • Action
    Users should inspect stocks and quarantine all units of IBRE51021 Lot EMU124, then complete and return the supplied Reply Form as directed for stock to be recovered and replaced.Complete the Reply Form even if you have no stock which is subject to recall, as Abacus ASL requires this information to reconcile this process. Retain the letter in a prominent position for one month in case stock is in transit. If any affected stock has been transferred from your Laboratory to another, immediately let that laboratory know of the recall and inform Abacus ASL.

Device

RE51021 / MuSK-Ab ELISA
  • Model / Serial
    RE51021 / MuSK-Ab ELISA Lot EMU124ARTG number: 210637
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd