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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