Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Recall #Z-1231-2020 — Class II — December 18, 2019
Product Description
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
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
824 units
Distribution
US Nationwide
Code Information
UDI Number: 00630414595795 Lots: All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated