Events

Recall of QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). 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-2016-RN-01084-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01084-1
  • 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 manufacturer has determined that the affected lot may yield over-quantitation in patient samples. the manufacturer has conducted an internal assessment of product performance, and determined that over-recovery of whole blood assay results in the sub-therapeutic range by as much as 50% (for example, a reported assay result of 3.75 ng/ml instead of the actual whole blood concentration of 2.5 ng/ml). given standardised medication toxicity and close monitoring of patients for markers of efficacy, the risk of developing serious or long-range adverse health consequences due to a single reported erroneous everolimus concentration result is deemed to be negligible.
  • Action
    Thermofisher is advising users to discontinue use and destroy any remaining stocks of the affected batch. A credit note will be issued for the affected product. A review of previously generated results should be considered by the laboratory director and treating physician.

Device

QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An i...
  • Model / Serial
    QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An in vitro diagnostic medical device (IVD)Catalogue Number: 0373852Lot Number: 72258007Expiry Date: 31 July 2017ARTG Number 235822
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific