Class 2 Device Recall AxSYM Ultrasensitive hTSH II Master Calibrators

• Date Initiated by Firm: March 06, 2008
• Date Posted: July 24, 2008
• Recall Status: Terminated on January 25, 2012
• Recall Number: Z-1566-2008
• Recall Event ID: 47203
• 510(K)Number: K952148
• Product Classification: Calibrator - Product Code JIS
• Product: AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
• Code Information: Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008
• Recalling Firm/ Manufacturer: Abbott Diagnostic International, Ltd.; Carr # 2 Km 58.0; Cruce Davila; Barceloneta PR 00617-3009
• For Additional Information Contact: Saritza Rios; 787-846-3500 Ext. 3352
• Manufacturer Reason for Recall: High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.
• Quantity in Commerce: 882 total units
• Distribution: Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.
• 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 = JIS