Events

Recall of Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. 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 Leica Microsystems 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-2016-RN-00069-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00069-1
  • 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
    Leica biosystems recently became aware that the product / detection kit combinations identified may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • Action
    Leica Biosystems is advising users to discontinue use of the listed antibodies / probes with the specified detection kits. There are alternative kits available for use. Leica is advising that there is no requirement for a review of previously reported results if appropriate positive controls were used.

Device

Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An...
  • Model / Serial
    Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An in vitro diagnostic medical device (IVD)Multiple antibody and probes affectedProduct Codes: PA0552,PA0210,PB0614,PB0589,PB0645,PB0669,PB0809,PB0785All lot numbers affectedAffected Bond Polymer Refine Detection KitsProduct Code: DS9800Lot Numbers: 42314,42388,42474,42486,42499,42555,42570,42579,42627,42645,42683,42780,42802,42823,42852,43050Expiry Dates: 02 April 2017 to 21 May 2017
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd