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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 December 04, 2002
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 14, 2004
Recall Number Z-1080-04
Recall Event ID 29178
Product Classification Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
Product FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP.

The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container.

Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.
Code Information Lot 012823 Exp October 2003
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 FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.
FDA Determined
Cause 2
Action Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.
Quantity in Commerce 965
Distribution The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
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.