Magnetic Silica (MagSIL) used in NucliSENS easyMAG nucleic acid extraction system 의 안전성 경고

Safety alert

2016-07-18

2016-07-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160718a.html

Medical device safety alert: biomérieux magnetic silica (magsil) used in nuclisens easymag nucleic acid extraction system medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its magnetic silica (magsil) (reference number: 280133) used in nuclisens easymag nucleic acid extraction system. the lot numbers affected by this issue are described below. lot numbers (expiration date): z0i7bb1ms (28/02/2017), z017bf1ms (28/02/2017), z017ca1ms (28/03/2017), z017be1ms (28/02/2017), z017cc1ms (28/03/2017), z017cd1ms (28/03/2017), z017ch1ms (28/03/2017), z017bd1ms (28/02/2017), z017db1ms (28/04/2017), z017ba1ms (28/02/2017), z017cf1ms (28/03/2017), z017ce1ms (28/03/2017), z017cg1ms (28/03/2017), z017da1ms (28/04/2017) , z017dc1ms (28/04/2017), z017dd1ms (28/04/2017), z017ea1ms (28/05/2017), z017eb1ms (28/05/2017), z017fb1ms (28/06/2017), z017fa1ms (28/06/2017), z017kc1ms (28/09/2017), z017kf1ms (28/09/2017), z017kg1ms (28/09/2017), z017kh1ms (28/09/2017), z017la1ms (28/10/2017) ]. following customer complaints about amplification performance issues with home brew pcr and rt-pcr assays, the manufacturer’s investigation has observed a decrease of extraction performances for some specific downstream applications due to the specific batches of magnetic silica (magsil). the investigation demonstrated no or not significant impact on performances when using nuclisens easymag extraction reagents with the biomerieux ivd downstream applications (pcr/rt-pcr argene) and nuclisens easyq hiv1 v2.0 (nasba technology). the investigation concluded that downstream applications were only 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 l200kbp). single stranded rna virus applications are not impacted unless the rna is extracted without a matrix (i.E. in water). according to the manufacturer, the decrease of downstream application performances can lead to a risk of false negative, invalid or under-quantification results. however, this risk can be managed by following good laboratory practice with the use of appropriate controls (ic with same nature/structure than the target and/or external controls) that should detect the issue, especially false negative or under-quantification results. product recall and replacement is on-going. the customers are advised to take the following actions: reduce the sample input volume to 200µl until the silica problem is solved. use an extraction internal control which mimic the target (with same nature/structure), and/or external controls as recommended in the ifu and in good laboratory practice to detect any extraction performance issue. discuss any concern regarding previously reported results with the laboratory medical director to determine the appropriate course of action. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 july 2016.