Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00363-1
Product Name/Description	Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic medical device (IVD). Lot Numbers: EB8115, BB8159, FB8275,17135BC, 17150BF, 17159BD, 17178AC, 17269BD,17312BB Serial Numbers: 10444927, 10445120 ARTG Number: 182220
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/05/2018
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare Diagnostics has confirmed Dimension Gentamicin (GENT) may exhibit inaccuracy for Quality Control (QC) and patient samples at the low end of the Analytical Measurement Range. Maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/L [1.94 µmol/L] and 1.9 mg/L [4.1 µmol/L], respectively. Patient samples at = 2.6 mg/L [5.62 µmol/L] did not show a bias. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.
Recall Action	Recall
Recall Action Instructions	Siemens is advising customers to inspect stock, discontinue use of and discard the affected Dimension and Dimension Vista GENT lots. This action has been closed out on 04/02/2020
Contact Information	1800 310 300 - Siemens Technical Support Centre