Events

Recall of Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.

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-2018-RN-00329-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00329-1
  • 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
    It has been identified that the primary labels of the affected vials of m0880 were mislabelled with an incorrect concentration. the concentration was written to be 187 mg/l. the correct concentration is 485 mg/l.To date, no customer complaints have been received as a result of this issue.
  • Action
    Agilent Technologies is advising customers to discard any bottles of the affected lots of this product in line with the precautions outlined in the IFU. Agilent will provide replacement product to affected sites who hold unused or partially used vials. Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.

Device

Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical de...
  • Model / Serial
    Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.Code Number: M0880 Lot Numbers: 20033445 and 20042272ARTG Number:183436(Agilent Technologies Australia - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd