Class 3 Device Recall Wako Autokit Lp(a) Calibrator

• Date Initiated by Firm: January 30, 2012
• Date Posted: April 06, 2012
• Recall Status: Terminated on May 02, 2012
• Recall Number: Z-1377-2012
• Recall Event ID: 61084
• 510(K)Number: K981446
• Product Classification: Lipoprotein, low-density, antigen, antiserum, control - Product Code DFC
• Product: Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
• Code Information: Lot No.: DJ427, Exp 08-31-12
• FEI Number: 3005625991
• Recalling Firm/ Manufacturer: Wako Chemicals USA, Inc.; 1600 Bellwood Rd; Richmond VA 23237-1326
• For Additional Information Contact: Technical Support Team ; 877-714-1924
• Manufacturer Reason for Recall: In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
• FDA Determined Cause: Device Design
• Action: Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.
• Quantity in Commerce: 10 kits
• Distribution: The product had been sold to 2 customers in the US.
• 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 = DFC