ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modules 의 리콜

Recall

RC-2017-RN-00374-1

Class II

2017-03-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00374-1

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.

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.