Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 1355 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Canada, Switzerland, Germany, Denmark, Spain, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Norway, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan. |
| Initiated | 2015-04-29 |
| Classified | 2015-06-30 |
| Terminated | 2017-05-11 |
| Recall number | Z-1942-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-1942-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71204/
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