Events

Recall of Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. 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-01482-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01482-1
  • 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 certificate of analysis (coa) and the primary labels of the affected vials of m3636 were mislabelled with an incorrect protein concentration value of 292.7 mg/l, which is sixteen times higher than the correct concentration of 18.3 mg/l. to date, agilent has received only one customer complaint about this issue. the customer detected the issue prior to testing and immediately contacted agilent. no patient harm was reported, and the customer had informed that they were able to complete the patient’s diagnostic testing with minimal delay.M3636 will perform as expected. there is no change to the concentration itself, just the incorrect concentration stated on the vial label and the coa. the secondary label (box label) contains the correct concentration of 18.3 mg/l.
  • Action
    Agilent Technologies Australia is advising customers to discard any affected vials of Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2, Code No. M3636 in accordance with the IFU. Agilent Technologies will arrange for replacement of product from affected customers. 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 CDX2, Clone DAK-CDX2. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. An in vitro diagnostic medical device (IVD)Product number: M3636Material Number: M363629-2Lot Number:10121365 Material Number: M363601-2Lot Number:10117361ARTG Number: 269420
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd