Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Imprecision with certain lots |
| Product | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay |
| Quantity | 4963 |
| Distribution | Worldwide Distribution - USA (nationwide) and Mexico. |
| Initiated | 2013-08-30 |
| Classified | 2013-11-07 |
| Terminated | 2014-08-27 |
| Recall number | Z-0181-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0181-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66267/
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