Siemens EasyLink Informatics System V4 — Class II medical device recall Z-2561-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-09-10, distributed nationwide. May not perform as intended under certain conditions, causing the release of results to the Laboratory Informa
| Recall number | Z-2561-2014 |
|---|---|
| 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 | 2013-08-13 |
| Classified | 2014-09-01 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2014-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,347 |
Product
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
Reason for recall
May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
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-2561-2014. 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.