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U.S. Department of Health and Human Services

Class 2 Device Recall STA Neoplastine CI Plus 10

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  Class 2 Device Recall STA Neoplastine CI Plus 10 see related information
Date Initiated by Firm October 20, 2008
Date Posted December 18, 2008
Recall Status1 Terminated 3 on June 24, 2010
Recall Number Z-0502-2009
Recall Event ID 50125
Product Classification Prothrombin Time Test - Product Code GJS
Product STA Neoplastine CI Plus 10; Product Catalogue Number: 0667
Manufactured by Diagnostica Stago, Asnieres, France.
Code Information Lot 100439, Lot 101126, Lot 101601, Lot 100755, Lot 101231, Lot 101602, Lot 100975, Lot 101419, Lot 101726, Lot 100995, Lot 101420, Lot 101856, Lot 101002, Lot 101600, and Lot 101955. 
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact Umberto V. Parrotta
973-631-1200 Ext. 2044
Manufacturer Reason
for Recall		 Internal investigation has determined the potential lack of homogeneity between product vials.
FDA Determined
Cause 2		 Process control
Action Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached "Product Recall Response Form" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.
Quantity in Commerce 31,207 units
Distribution Nationwide Distribution.
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.
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