cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00625-1

Class III

2017-05-15

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00625-1

Through routine quality stability monitoring, roche has been made aware that certain lots of the cobas 4800 hpv amplification/detection kit are generating an increase in the frequency of invalid positive control (pc) results, causing the entire run to be invalidated on the cobas 4800 system. as a precautionary measure, roche has additionally temporarily shortened expiration dates for other selected lots of these kits to reduce the potential for invalid pc result generation.

Roche Diagnostics is requesting users with affected lots (as reflected in Table 1 of the recall notification) to immediately discontinue use of and discard the indicated lots. Users with affected lots (as reflected in Table 2) are advised to be aware of and adhere to the revised expiry date of the indicated lots. (Users are to note that the cobas 4800 System will not recognise nor flag the revised expiry of the affected kits. Therefore, close attention must be paid to the expiry dates listed in Table 2 and appropriate action taken accordingly.) Users will be assisted with the process of supply of replacement kits.