FDA Device recall Z-0847-2019
VITEK 2 AST-N351 Test Kit
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of VITEK 2 AST-N351 Test Kit by Biomerieux, citing false Positive ESBL Phenotype.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0847-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-13 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
VITEK 2 AST-N351 Test Kit
Reason
False Positive ESBL Phenotype
Identifiers
| code_info | Ref: 421257 ALL LOTS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2019%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.