FDA Device recall Z-0977-2017
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extra…
- FDA Device
- Class I
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class I recall of NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extra… 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-0977-2017 |
| 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
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids 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: 200293, Lot number: 16072701. |
|---|
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-0977-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.