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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01117-1
Product Name/Description	Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs). Assay Name: Dimension Opiates Catalogue Number: DF93A Siemens Material Number: 10444923 Assay Name: Dimension Vista Opiates Catalogue Numbers: K5093 Siemens Material Number: 10445114 All Lots, including all future lots until the IFU is updated ARTG Number: 182221
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/08/2016
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare Diagnostics has determined that the concentrations for some of the cross reactants listed in the Specificity Section of the Dimension Opiates assay Instructions For Use and the Cross-reactivity Section of the Dimension Vista Opiates assay Instructions For use are incorrect. Siemens has revised the concentrations, which will enable the correct interpretation on how cross reactants can affect test results. The Instructions For Use for the Opiates assay will be updated with the correct concentrations when Siemens completes their investigation of the issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising users to review the revised cross-reactant concentrations for Levallorphan, Levorphanol, Nalorphone and Oxycodone that are provided in the recall correspondence with their Medical Director. The decision to perform a look-back should be at the discretion of the Medical Director. Siemens will be updating the IFU with the revised concentrations once they have completed their investigation of the issue. This action has been closed out on 19/10/2018
Contact Information	1800 310 300 - Siemens Technical Support Centre