Events

Recall of Xpert EV 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-2017-RN-01257-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01257-1
  • 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
    Customers have reported a higher than expected number of invalid test results or probe check low (e5007) errors when using the affected product.Patient results are not reported for invalid tests and the test report is designated as “invalid”.
  • Action
    Cepheid is advising users to stop using the affected product. Any remaining product should be discarded. Cepheid will provide replacement product.

Device

Xpert EV Assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Xpert EV Assay. An in vitro diagnostic medical device (IVD)Part Number: GXEV-100N-10Batch Number: 1000045409Lot Number: 06802Expiry Date: 04 November 2018ARTG Number: 221804
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd