FDA-Device2020-02-26Class II
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
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
11,725 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2020Don't want to check this manually?
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