FDA-Device2018-06-13Class II
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Siemens Healthcare Diagnostics, Inc.
Hazard
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Sold states
Nationwide and worldwide
Affected count
N/A
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2018Don't want to check this manually?
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