FDA Device recall Z-0181-2014
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay by Siemens Healthcare Diagnostics, citing imprecision with certain lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0181-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-30 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Reason
Imprecision with certain lots
Identifiers
| code_info | Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2014%22
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