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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