Class 3 Device Recall Utak NR Trace Elements Serum Control

• Date Initiated by Firm: March 20, 2020
• Create Date: June 22, 2020
• Recall Status: Terminated on July 22, 2020
• Recall Number: Z-2407-2020
• Recall Event ID: 85660
• 510(K)Number: K883147
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
• Code Information: Lot C2540
• Recalling Firm/ Manufacturer: Utak Laboratories Inc; 25020 Avenue Tibbitts; Valencia CA 91355-3447
• For Additional Information Contact: Matt Kopp; 800-235-3442
• Manufacturer Reason for Recall: The product has an incorrect reference value for cadmium and an incorrect expected range.
• FDA Determined Cause: Labeling Change Control
• Action: The recalling firm issued a recall letter dated 3/19/2020 via email on 3/20/2020 requesting customers to destroy the incorrect IFU and replace it with the revised IFU.
• Quantity in Commerce: 1,395 vials
• Distribution: Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
• 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 = JJY