medical Class II Updated 2020-02-26

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 1

Recalled Product

ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI Number: 00630414526690 Lots: All lots
View official government recall

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