Events

Recall of FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. 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 Agilent Technologies Australia 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-01330-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01330-1
  • 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
    Agilent has determined that a specific lot of flex monoclonal rabbit anti-human estrogen receptor clone ep1 has shown weak non-specific nuclear and cytoplasmic / stomal staining in known negative samples. in this affected lot some, but not all, breast cancer samples will show weak false-positive staining in some nuclei. this could result in a false-positive result in patient tissue and may not be detected by run controls.To date, agilent has not received any customer complaints regarding this issue.
  • Action
    Agilent Technologies is advising users to discard affected Ready-to-Use GA084 vials from the affected lots. The vials should be discarded in accordance with the precautions in the Instructions For Use. Agilent will be providing affected users with replacement product in lieu of GA084. Laboratory Managers should review assay runs and patient results where the affected lots were used.

Device

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnost...
  • Model / Serial
    FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD).Code Number: GA084Lot Number: 10125849Expiry: 31 March 2018ARTG Number: 183436 (Agilent Technologies Australia Pty Ltd - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd