Recall Z-0976-2017 ยท PPM General Purpose Reagent
BioMerieux SA
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS easyMAG system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
| Date | Jan 13, 2017 (initiated Nov 23, 2016) |
| Status | Terminated |
| Reason | A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016. |
| Quantity | 3723 units in total |
| Distribution | Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.