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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00873-1
Product Name/Description	Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay) Affected lot numbers that have been supplied: 539267, 539267B, 539273, 539280, 539281, 539298, 539301, 539303A, 539305, 539306, 539309 ARTG Number: 178501
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/09/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens have identified that majority of current lots of this product are affected by reduced reagent stability after reconstitution.. Affected lots were identified before release during regular quality control processes and became part of an extended testing program to verify reagent stability. There has been no impact on product performance within the reduced stability.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising end users that reduced in use stability claims will be indicated on a ‘Pink Note’ included with the kits. This action has been closed-out on 31/05/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre