FDA Device recall Z-2553-2014
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids
- FDA Device
- Class II
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class II recall of Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids by Siemens Healthcare Diagnostics, citing the Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2553-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-16 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
Reason
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Identifiers
| code_info | All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338 |
|---|
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-2553-2014%22
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