Emit — Class II medical device recall Z-0664-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-01-16, distributed in CA, FL, IL, KS, MA, MI, MN, MS…. Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R)
| Recall number | Z-0664-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2012-12-10 |
| Classified | 2013-01-10 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2014-08-27 |
| Distributed | CA, FL, IL, KS, MA, MI, MN, MS, NC, NM, NY, OH, OR, PA, TN, TX, UT, WA |
| Quantity | 1,979 cartons |
| Lot numbers | 1237, 1264 |
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 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) 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0664-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.