Emit — Class II medical device recall Z-0030-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2012-10-17, distributed nationwide. Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the S
| Recall number | Z-0030-2013 |
|---|---|
| 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 | 2012-07-30 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 79,744 cartons |
| Reason classes | potency |
| Lot numbers | 1151, 1167, 1191, 1212 |
Product
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Reason for recall
Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs
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-0030-2013. 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.