FDA-Device2020-02-26Class II
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
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
824 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1231-2020Don't want to check this manually?
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