FDA-Device2014-01-29Class II
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Siemens Healthcare Diagnostics, Inc.
Hazard
An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
Sold states
Worldwide Distribution. USA nationwide and the country of Canada.
Affected count
1563
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0800-2014Don't want to check this manually?
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