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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00680-1
Product Name/Description	Dimension Creatinine and Dimension Vista Creatinine Assays. An in vitro diagnostic medical device (IVD) Dimension CREA Assay Catalogue Number: DF33A Siemens Material Number (SMN): 10444968 Dimension Vista CREA Assay Catalogue Number: K1033 Siemens Material Number (SMN): 10445161 All in-date and future lots are affected ARTG number: 181689
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/07/2015
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare Diagnostics has determined that Dimension Creatinine (CREA) may produce depressed results up to 12.7% (or approximately 18 µmol/L) for a creatinine result at 133 µmol/L when haemolysis exceeds 300 mg/dL [0.19 mmol/L] of haemoglobin. Dimension Vista Creatinine (CREA) may produce depressed results up to 22% (or approximately 27 ìmol/L) for a creatinine result at 133 ìmol/L when haemolysis exceeds 200 mg/dL [0.12 mmol/L] of haemoglobin. Depressed creatinine results due to haemolysis would not be expected to significantly impact medical decisions when using this assay. The potential for injury is remote due to continued monitoring, additional diagnostic testing and correlation to patient history and presentation.
Recall Action	Recall for Product Correction
Recall Action Instructions	A workaround is provided in the form of revised interference information via the Customer Letter. This action has been closed out on the 17/10/2018.
Contact Information	1800 310 300 - Siemens Technical Support Centre