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U.S. Department of Health and Human Services

Class 2 Device Recall American Diagnostica Inc.

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  Class 2 Device Recall American Diagnostica Inc. see related information
Date Initiated by Firm February 28, 2007
Date Posted May 03, 2007
Recall Status1 Terminated 3 on July 06, 2016
Recall Number Z-0779-2007
Recall Event ID 37762
510(K)Number K052124  
Product Classification in vitro diagnostic - Product Code GIR
Product American Diagnostica Inc. ACTICLOT dPT
Reference 824 in vitro diagnostic
Code Information Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20
Recalling Firm/
Manufacturer		 American Diagnostica, Inc.
500 West Ave
Stamford CT 06902-6360
Manufacturer Reason
for Recall		 Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
FDA Determined
Cause 2		 Other
Action American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.
Quantity in Commerce 249 kits
Distribution Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.
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 = GIR and Original Applicant = AMERICAN DIAGNOSTICA, INC.
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