Events

Recall of Thermo Scientific MAS Omni-IMMUNE PRO. 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 Thermo Fisher Scientific.

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-2014-RN-00024-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00024-1
  • 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
    The constituent, inhibin a, was removed for mas omni-immune and mas omni-immune pro controls; however the package insert was not updated to reflect removal. the affected lots should not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.This action was undertaken prior to approval of the recall strategy by the tga.
  • Action
    Thermo Fisher Scientific is advising users to destroy any remaining stock of the affected lot numbers. An alternative product is available for use by affected users.

Device

Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD) Catalogue Numbers: OPRO-101, OPRO-202, OPRO-303, OPRO -SPLot Numbers: OPRO15101, OPRO15102, OPRO15103, OPRO1510S
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific