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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00712-1
Product Name/Description ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD)

ONLINE TDM Gentamicin, 100 tests
Material Number: 04490843190
Lot Numbers: 119166, 611780, 617623

ONLINE TDM Gentamicin, 100 tests
Material Number: 05841291190
Lot Numbers: 119167, 611783, 617624

Preciset TDM I Calibrator
Material Number: 03375790190
Lot Numbers: 615118, 619681, 126387, 140735

ARTG Number: 174910
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/05/2016
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Investigations by Roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of ONLINE TDM Gentamicin with Preciset TDM I Calibrator. A combination with TDM control set lot 125783 does not show this effect. This may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.
Recall Action Recall
Recall Action Instructions Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS

(except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems. This action has been closed-out on 15/02/2017.
Contact Information 02 9860 2313 - Roche Diagnostics Australia