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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm October 26, 2005
Date Posted January 20, 2006
Recall Status1 Terminated 3 on March 01, 2006
Recall Number Z-0408-06
Recall Event ID 34011
Product Classification Test, Qualitative And Quantitative Factor Deficiency - Product Code GGP
Product STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
Code Information Lot 0422671 exp. March 2006.
Recalling Firm/
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact James Barrow
973-631-1200 Ext. 116
Manufacturer Reason
for Recall
The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
FDA Determined
Cause 2
Action Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.
Quantity in Commerce 150 units
Distribution Product was distributed to 23 direct account customers 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.