Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00002-1
Product Name/Description Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical diagnostic device (IVD)

OptiView DAB IHC Detection Kit
Marial Number 06396500001
Lot Number Y11625, Y15571, Y19271

ultraView DAB IHC Detection Kit
Material Number 05269806001
Lot Number Y09284, Y15384

OptiView Amplification Kit
Material Number 06396518001
Lot Numbers: Y15435, Y19322

Hematoxylin II
Material Number 05277965001
Lots: Y10759, Y13938, Y17402, Y17403, Y21312, Y22561

ARTG 174896 and 174922
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/01/2018
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.

This action has been closed out on 11/02/2019
Contact Information 02 9860 2222 - Customer Support Centre