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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00153-1
Product Name/Description	Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs) PHOS Flex Reagent Cartridge Catalogue Number: DF61 Material Number: 10444951 EZCR Flex Reagent Cartridge Catalogue Number: DF270B Material Number: 10471520 ARTG Number: 181686
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/02/2013
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens have confirmed customer complaints of falsely depressed creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent. The inaccurate EZCR results are caused by a reagent interaction that occurs when vapour from PHOS reagent is absorbed by open wells of the EXCR Flex reagent cartridge. Both Quality Control (QC) samples and patient samples are affected.
Recall Action	Recall for Product Correction
Recall Action Instructions	If both Enzymatic Creatinine and Phosphorus are tested using the instrument, customers are requested to discontinue the use of one of the tests. Customers with two or more Dimension systems should perform testing of Enzymatic Creatinine and Phosphorus on separate instruments. This action has been closed-out on 12/02/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre