FDA-Device2014-09-03Class II
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.
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Nationwide and internationally, including Canada and Mexico
Affected count
2757
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
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, 10486890, 10472176, 10639337, and 10639338.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2014Don't want to check this manually?
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