BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00806-1

Class I

2017-06-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00806-1

Biomérieux has observed significant differences between the fit point and 2nd derivative analysis methods on lightcycler amplification platforms for low positive whole blood samples.Investigation showed that the significant differences (>0,5 log10 cp/ml) have been obtained for bk virus low viral loads (inferior to around 25 000 cp/ml - corresponding to around 4.40 log10 cp/ml - determined by fit point) on whole blood samples with the bk virus r-gene assay. these differences between the two methods are due to the shape of the curves for low positive whole blood samples.

Users are requested to take the following actions at this time: ? Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. ? Stop using the 2nd derivative method for whole blood samples on LightCycler 1.0, 2.0 and 480 until the improved BK Virus R-gene kit was released. Use the Fit Point method with these LightCyclers. ? Contact your local customer service if you observe the issue.