Recall of Cell Marque Rabbit Monoclonal Antibody. 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 Abacus ALS 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Cell marque has become aware certain lots of the rabbit monoclonal antibody exhibit an unacceptable immunohistochemistry (ihc ) test result. an investigation was undertaken which showed that lots 1335409a to 1335409f may exhibit a false negative result. false negative results are readily detected when appropriate tissue controls are used during testing. the manufacturer recommends the use of proper controls when performing ihc staining to detect this issue.
  • Action
    Abacus ALS is advising users to destroy any remaining kits of the affected lots. Affected product will be replaced with unaffected kits or credit issued. This action has been closed-out on 02/03/2017.


  • Model / Serial
    Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)Product Code: S100A1 (EP184)Affected products: Cell Marque S100A1 rabbit EP184 0.1 concentrate Catalogue Number: 408R-14Cell Marque S100A1 rabbit EP184 1 concentrateCatalogue Number: 408R-16Lot numbers: 1335409A to1335409FARTG Number: 239099
  • Manufacturer