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Recall Observatory FDA recall evidence

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

July 16, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

    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.