Class 2 Device Recall Dimension Enzymatic Creatinine (EZCR) reagent

• Date Initiated by Firm: December 18, 2019
• Date Posted: January 24, 2020
• Recall Status: Terminated on June 25, 2020
• Recall Number: Z-1232-2020
• Recall Event ID: 84612
• 510(K)Number: K073055
• Product Classification: Enzymatic method, creatinine - Product Code JFY
• Product: Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
• Code Information: UDI Number: 00842768030512 Lots: All lots
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: 914-631-8000
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
• Quantity in Commerce: 2,198 units
• Distribution: US Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JFY