Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: 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.

Agency Publication Date: January 24, 2020

Affected Products

Product: ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

UDI Number: 00630414526690 Lots: All lots

Product: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

UDI Number: 00630414595795 Lots: All lots

Product: Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520

UDI Number: 00842768030512 Lots: All lots

Product: Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

UDI Number: 00842768036262 Lots: All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84612

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Manufactured In: United States

Units Affected: 4 products (1,015 units; 824 units; 2,198 units; 11,725 units)

Agency Last Updated: February 14, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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