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U.S. Department of Health and Human Services

Class 3 Device Recall STA Liatest

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  Class 3 Device Recall STA Liatest see related information
Date Initiated by Firm May 08, 2007
Date Posted August 09, 2007
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1072-2007
Recall Event ID 37952
510(K)Number K912468  
Product Classification in vitro diagnostic - Product Code GGP
Product STA Liatest Free Protein S
For in vitro diagnostic use.
2-8 degrees C
Distributed in the USA by:
Diagnostica Stago, Inc.
5 Century Drive
Parsippany, NJ
Phone 800-abc coag

1 - 6 x 5 ml Buffer
2 - 6 x 6 ml Latex
Code Information Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07;  061991, Exp 8/31/07;  062633, Exp 10/31/07;  063281, Exp 12/31/07
Recalling Firm/
Manufacturer
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact Melissa Cole
973-631-1200 Ext. 4416
Manufacturer Reason
for Recall
Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
FDA Determined
Cause 2
Other
Action Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
Quantity in Commerce 365 units
Distribution Medical facilities nationwide
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 = GGP and Original Applicant = AMERICAN BIOPRODUCTS CO.
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