FDADecember 18, 2019device

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00842768036262

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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