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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00608-1
Product Name/Description	ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra ReadyPack. An in vitro diagnostic medical device (IVD). Catalogue Numbers: 02789602 (100 tests) and 02790309 (500 tests) Lot Numbers: Kit Lots ending in 078 Expiration: 18 July, 2014 Kit Lots ending in 079 Expiration: 18 July 2014 Kit Lots ending in 082 Expiration: 27 September, 2014 Kit Lots ending in 083 Expiration: 29 November, 2014 Kit Lots ending in 084 Expiration: 28 December 2014
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/06/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Manufacturer confirms that the solid phase reagent in some of the ADVIA Centaur TNI-Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing work around instructions to users. Only one TNI-Ultra ReadyPack is to be used on a system at one time. Patient results produced by the assay are acceptable if they follow acceptable calibration with valid quality control results. Kit lots ending in 086 or higher do not require calibration of each ReadyPack, refer IFU for the calibration interval. This action has been closed-out on 11/04/2016.
Contact Information	1800 310 300 - Siemens Technical Centre