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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Recalled February 26, 2020 · FDA recall Z-1230-2020 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
1,015 units
Sold at
US Nationwide
Description
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.
Product
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →