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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00739-1
Product Name/Description	ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD) Urea Nitrogen Assay Catalogue Number: 03040257 Lot Numbers: 321973, 333872 Expiry date: 2015-11 Lot Number: 348126 Expiry date: 2016-06 Urea Nitrogen Concentrated Assay Catalogue Number: 06860558 Lot Number: 321967 Expiry date: 2015-11 Lot Number: 332365 Expiry date: 2016-03 ARTG Number: 176642
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	12/08/2015
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare Diagnostics has confirmed that Urea Nitrogen reagent kit lots listed and Urea Nitrogen concentrated reagent kit lots listed for use on ADVIA 1200, 1650, 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. Failed calibration may lead to a slight delay in results until a replacement or suitable material to perform the calibration verification is obtained. The risk to health is negligible.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising users that if they experience this issue, to request unaffected replacement product. Siemens is not recommending a review of previously generated results. This action has been closed-out on 07/09/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre