FDA Device recall Z-0218-2019
NucliSENS¿ Magnetic Extraction Reagents
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of NucliSENS¿ Magnetic Extraction Reagents by Biomerieux, citing data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0218-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-17 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
NucliSENS¿ Magnetic Extraction Reagents
Reason
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
Identifiers
| code_info | Reference # 200293, Lot # 17121501, Expiration date 11/28/2018 |
|---|
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-0218-2019%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.