FDA-Device2020-02-26Class II
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Siemens Healthcare Diagnostics, Inc.
Hazard
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Sold states
US Nationwide
Affected count
1,015 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1230-2020Don't want to check this manually?
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