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

Recall

RC-2016-RN-01551-1

Class I

2017-01-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01551-1

In july 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with specific batches of magnetic silica (magsil). the investigation concluded that downstream applications were impacted when the extraction volume was higher than 400µl and for double stranded nucleic acids target. double stranded nucleic acid applications with small (< 40kbp) and medium genome sizes (< to 1200 kbp) i.E., dna viruses are more impacted than higher human genomic dna and bacterial applications (> to 1200kbp). the decrease of downstream application performances can lead to a risk of false negative, invalid or under-quantification results. if invalid results are obtained, it could lead to a delayed result until a new run or a new extraction is performed. since, biomérieux has identified subsequent batches that may be affected.

bioMérieux is advising users to ensure controls with the same nature/structure as the target and/or external controls are used to detect the issue. Users are advised to reduce the sample input volume to 200µL until the silica problems is resolved. Downstream ARGENE and NucliSENS easyQ HIV 1 V2.0 applications performed according to the IFU are not affected. It is recommended that the continued use with blood transfusion testing is confirmed by the Laboratory Director, and to discuss any concerns regarding previously reported results with the Laboratory Director.