BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00141-1

Class II

2017-01-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00141-1

Following a customer complaint and an internal investigation, biomérieux has confirmed that when testing weak viral load samples, in conjunction with bk virus r-gene kit on smartcycler 2.0 platform, negative results may be obtained instead of positive as expected. the investigation confirmed that the issue has been observed only with smartcycler 2.0 and the issue only concerns low viral load samples (viral load equal or below the sensitivity control). the issue is detected by the sensitivity control (sc) that is the equivalent of a weak positive sample, which will be systematically negative instead of positive in most of the cases. when no sensitivity control is systematically run, there is a potential risk to obtain a false negative result. based on the investigation data, the performances claimed in the ifu regarding the use of smartcycler 2.0 in conjunction with bk virus r-gene kit could not be warranted.

bioMérieux is advising customers to stop using the BK Virus R-gene kit ref. 69-013B on Smart Cycler 2.0. It is recommended that any concern customers have regarding previously reported results is discussed with the Laboratory Medical Director to determine the appropriate course of action.