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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00374-1
Product Name/Description ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)

cobas c 501/502 modules
Material Number: 04490843190

cobas c 701/702 modules
Material Number: 05841291190

ARTG Number: 174910
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/03/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue On 30 May 2016, customers using the ONLINE TDM Gentamicin (GENT2) assays were advised to stop using certain lots of the assay due to reports of increased recovery in patient results. (Customers would also have received the Customer Bulletin Reference Number: CC16-029, notifying that the ONLINE TDM Gentamicin assay was once again available for use following the implementation of a mandatory instrument factor (a = 0.8) and re-assignment of the TDM Control Set values.)

Several reports have since been received that after the instrument factor (IF) was implemented, decreased recovery of patient results were observed. Further internal investigations suggested that the IF of 0.8 is incorrect, leading to decreased recovery of gentamicin results. This may lead to over dosage, which would cause potential toxic concentrations in patients.
Recall Action Recall for Product Correction
Recall Action Instructions Roche Diagnostics Australia (Roche) is requesting users NOT to implement the IF of 0.8 on cobas c 501/502/701/702 modules. Users are further requested to reset or leave the IF at1.0 and set the technical limit back to the original values. Roche has released re-assigned control values (which have to be implemented) via updated e-packages and would like to advise users that work a on a long term solution to correct the issue is still underway. Users are requested to follow further instructions as detailed in their recall notification letter.
This action has been closed-out on 22/03/2018.
Contact Information 02 9860 2357 - Roche Diagnostics Australia