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U.S. Department of Health and Human Services

Class 3 Device Recall STA

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  Class 3 Device Recall STA see related information
Date Initiated by Firm March 30, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on November 30, 2009
Recall Number Z-0979-2007
Recall Event ID 37834
510(K)Number K922040  
Product Classification in vitro diagnostic - Product Code GJS
Product STA Neoplastine CI Plus (10), (cat. 0667).
12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Code Information Lot 061781, June 2008
Recalling Firm/
Manufacturer
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact Melissa Cole
800-222-2624 Ext. 4416
Manufacturer Reason
for Recall
Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
FDA Determined
Cause 2
Other
Action Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
Quantity in Commerce 170 units
Distribution 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 = GJS and Original Applicant = AMERICAN BIOPRODUCTS CO.
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