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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