Events

Recall of Thermo Scientific MAS CardioImmune XL

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-01122-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01122-1
  • 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
    Due to a manufacturing production error, mas cardioimmune xl, level 1 (lot cxl16011), is showing vial-to-vial variation for the analytes creatine kinase-mb (ck-mb) and b-type natriuretic peptide-32 (bnp-32).

Device

Thermo Scientific MAS CardioImmune XL
  • Model / Serial
    Thermo Scientific MAS CardioImmune XLCatalogue Number: CAI-XL1Lot Number: CXL16011Expiration Date: 31/01/2016
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific