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U.S. Department of Health and Human Services

Class 2 Device Recall Access free T3 Reagent kit

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  Class 2 Device Recall Access free T3 Reagent kit see related information
Date Initiated by Firm August 31, 2015
Date Posted October 07, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall Number Z-0110-2016
Recall Event ID 72090
510(K)Number K960913  
Product Classification Radioimmunoassay, total triiodothyronine - Product Code CDP
Product Access Free T3 Reagent Kit, P/N A13422

The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Code Information Lot: 431433 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Rula Melconian
714-961-4295
Manufacturer Reason
for Recall		 Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beckman Coulter sent an " Urgent Medical Device Recall" letter dated August 31, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that some Access Free T3 reagent packs (p/n A13422) of lot 431433 were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at http://ww.beckmancoulter.com; call (800) 854-3633 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter representative.
Quantity in Commerce 16,648 units total (1874 units in US)
Distribution Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
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 = CDP and Original Applicant = BIO-RAD LABORATORIES, INC.
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