FDA Device recall Z-0976-2017
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is i…
- FDA Device
- Class I
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class I recall of MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is i… by Biomerieux, citing 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 recal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0976-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-11-23 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Reference number: 280133, Lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS, Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS and Z017ND1MS. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0976-2017%22
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