Drug recall
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous…
FDA recall event 63892 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 63892 |
|---|---|
| Recall numbers | Z-0664-2013 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R)… |
| Initiation date | Dec 10, 2012 |
| Report date | Jan 16, 2013 |
| Termination date | Aug 27, 2014 |
| City | Newark |
| State | DE |
| Country | United States |
| FEI number | 2517506 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: