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Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

FDA Recall #Z-1233-2020 — Class II — December 18, 2019

Recall #Z-1233-2020 Date: December 18, 2019 Classification: Class II Status: Terminated

Product Description

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

Reason for Recall

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.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

11,725 units

Distribution

US Nationwide

Code Information

UDI Number: 00842768036262 Lots: All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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