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U.S. Department of Health and Human Services

Class 3 Device Recall Free T4 Control Pack

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  Class 3 Device Recall Free T4 Control Pack see related information
Date Initiated by Firm May 30, 2003
Date Posted August 13, 2003
Recall Status1 Terminated 3 on September 16, 2003
Recall Number Z-1130-03
Recall Event ID 26430
510(K)Number K934544  
Product Classification Radioimmunoassay, Free Thyroxine - Product Code CEC
Product Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064
Code Information List 9C03-10, lot numbers 95881Q100 and 95881Q101
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Abbott Customer Service
877-422-2688
Manufacturer Reason
for Recall		 The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
FDA Determined
Cause 2		 Other
Action The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.
Quantity in Commerce 3247 kits
Distribution Nationwide and internationally to Abbott subsidiaries in Ecuador, Uruguay, Argentina, Brazil, El Salvador, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Costa Rica, Grenada, St. Lucia, Bermuda, Antigua, Panama, Guatemala, Mexico, Colombia, Jamaica, Paraguay, Peru, Chile, Dominican Republic, United Kingdom, New Zealand, Trinidad & Tabago, St. Vincent, Barbados, Curacao, St. Kitts, Anguilla, Turks & Caicos Islands, Cayman Islands, Germany and Taiwan.
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 = CEC and Original Applicant = ABBOTT LABORATORIES
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