FDA Device

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.

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.

What You Should Do

Remedy

Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.

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Products

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, 1048689
Brand
Siemens Healthcare Diagnostics, Inc.
UPC
All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338

Units Affected

2757

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