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Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Recalled February 26, 2020 · FDA recall Z-1233-2020 · 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
11,725 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
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →