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U.S. Department of Health and Human Services

Class 3 Device Recall NEFA Standard

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  Class 3 Device Recall NEFA Standard see related information
Date Initiated by Firm March 30, 2007
Date Posted July 12, 2007
Recall Status1 Terminated 3 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
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 2		 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.
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