Class 3 Device Recall NEFA Standard

• Date Initiated by Firm: March 30, 2007
• Date Posted: July 12, 2007
• Recall Status: Terminated on July 24, 2007
• Recall Number: Z-1071-2007
• Recall Event ID: 37921
• Product Classification: in vitro diagnostic - Product Code JIT
• Product: NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***
• Code Information: Lot TQ087, Exp 02/29/08
• FEI Number: 3005625991
• Recalling Firm/ Manufacturer: Wako Chemicals USA, Inc.; 1600 Bellwood Rd; Richmond VA 23237-1326
• For Additional Information Contact: Lori Creasy; 804-714-1932
• Manufacturer Reason for Recall: Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
• FDA Determined Cause: Other
• Action: The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction.
• Quantity in Commerce: 94 cartons
• Distribution: Worldwide, including USA, Germany and Canada.
• 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.