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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Ultrasensitive hTSH II Master Calibrators

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  Class 2 Device Recall AxSYM Ultrasensitive hTSH II Master Calibrators see related information
Date Initiated by Firm March 06, 2008
Date Posted July 24, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ABBOTT LABORATORIES
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