FDA Device recall Z-0664-2013
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for…
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for… by Siemens Healthcare Diagnostics, citing 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 applic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0664-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-10 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, FL, IL, KS, MA, MI, MN, MS, NC, NM, NY, OH, OR, PA, TN, TX, UT, WA |
Product
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 serum or plasma.
Reason
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) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of
Identifiers
| code_info | Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3. |
|---|
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-0664-2013%22
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