FDA-Device2020-02-26Class II
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
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
2,198 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief