FDA Device recall Z-1944-2014
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573 by Siemens Healthcare Diagnostics, citing certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1944-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Reason
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
Identifiers
| code_info | syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B |
|---|
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-1944-2014%22
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