FDA Device recall Z-2305-2012
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions
- FDA Device
- Class II
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class II recall of syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions by Siemens Healthcare Diagnostics, citing when using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2305-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.
Reason
When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
Identifiers
| code_info | Version VA11B and all previously released versions. |
|---|
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-2305-2012%22
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