Events

Recall of Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-00002-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00002-1
  • 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
    Roche diagnostics have been made aware of issues regarding leaking and sticking reagent dispensers that may lead to the incomplete dispensing of a reagent required for the staining reaction. this in turn could result in light or absent staining, which without any mitigations, could cause a delay or an error in diagnosis.
  • Action
    The manufacturer is producing new lots and customers will be notified when corrected product is available. In the interim, affected kits may continue to be used by customers but the affected kits must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results. For assays that directly relate to clinical therapy decision making, it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative.

Device

Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices
  • Model / Serial
    Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devicesOptiView DAB IHC Detection Kit Marial Number 06396500001Lot Number Y11625, Y15571, Y19271ultraView DAB IHC Detection KitMaterial Number 05269806001Lot Number Y09284, Y15384OptiView Amplification Kit Material Number 06396518001Lot Numbers: Y15435, Y19322Hematoxylin IIMaterial Number 05277965001Lot Numbers: Y10759, Y13938, Y17402, Y17403, Y21312, Y22561ARTG 174896 and 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited