FDA Device recall Z-1942-2015
EasyLink Data Management System
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of EasyLink Data Management System by Siemens Healthcare Diagnostics, citing system Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1942-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Numbers: 10444799, 10444800, 10487219 |
|---|
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-1942-2015%22
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