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U.S. Department of Health and Human Services

Class 3 Device Recall Utak NR Trace Elements Serum Control

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  Class 3 Device Recall Utak NR Trace Elements Serum Control see related information
Date Initiated by Firm March 20, 2020
Create Date June 22, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = UTAK LABORATORIES, INC.
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