Events

Recall of Xpert MRSA/SA Blood Culture Assay. 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 Cepheid Holdings 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-2016-RN-01487-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01487-1
  • 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
    Cepheid has received reports that some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types. as in all xpert assays, when the test is determined to be invalid due to a failure of a cartridge or instrument quality check, no patient results are reported and the report designation is “invalid.”.
  • Action
    Cepheid is advising customers to stop using the affected lot and dispose of any remaining product of this lot in their inventory. Cepheid will provide replacement product. This action has been closed-out on 18/05/2017.

Device

Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXMRSA/SA-BC-CE-10Lot Number: 1000025828 (cartridge lot 12803)Expiry date: 2 April 2017ARTG Number: 242177
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd