Device 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.
Z-2553-2014
Product summary
- Event
- Event 68854
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2757
- Official record key
device-enforcement:Z-2553-2014
Official wording
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.
Code information: All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338
Distribution pattern: Nationwide and internationally, including Canada and Mexico
Derived failure modes
-
Unknown
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.