Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples) 의 리콜

Recall

RC-2017-RN-00224-1

Class I

2017-02-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00224-1

In july 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with 7 batches of magsil, which can lead to a risk of false negative, invalid or under-quantification results (tga ref.: rc-2016-rn-00949-1). following this action, biomérieux put in place several additional quality controls (qc) at the release of batches. the released batches performances have been monitored in real-time for stability. as a result, in jan 2017 customers were informed that the issue may affect a further 8 magsil batches (tga ref.: rc-2016-rn-01551-1).The corrective actions provided for the batches under rc-2016-rn-01551-1 remain appropriate. for the 7 batches included in the july 2017 action, a drift of the performance results was observed after a few months of release with the biomérieux bk-virus r-gene test. since one biomérieux assay is impacted, the usability of these batches with all biomérieux applications cannot be assured.

bioMérieux is advising customers to quarantine the remaining kit from lots Z017BB1MS, Z017BF1MS, Z017BA1MS, Z017CC1MS, Z017CG1MS, Z017DC1MS & Z017DD1MS. bioMérieux will arrange for the return of these kits and also credit/replacement. Any concerns regarding previously reported results should be discussed with the Laboratory Director to determine the appropriate course of action.