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Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes
Recalled September 3, 2014 · FDA recall Z-2553-2014 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
2757
Sold at
Nationwide and internationally, including Canada and Mexico
Description
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.
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →