EasyLink Data Management System — Class II medical device recall Z-1942-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-07-08, distributed nationwide. System Limitations and Software Issues related to the following features: Custom reference ranges, User-initia
| Recall number | Z-1942-2015 |
|---|---|
| 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 | 2015-04-29 |
| Classified | 2015-06-30 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FR, HK, IT, JP, KR, MY, NL, NO, NZ, PH, PT, SI, TW |
| Quantity | 1,355 |
| Reason classes | software |
| Model numbers | 10444799, 10444800, 10487219 |
Product
EasyLink Data Management System; 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
System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports.
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-1942-2015. 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.