Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recallsee related information
Date Initiated by FirmDecember 04, 2002
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 14, 2004
Recall NumberZ-1080-04
Recall Event ID 29178
Product Classification Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
ProductFDP 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/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information ContactJames 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		Other
ActionDiagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.
Quantity in Commerce965
DistributionThe firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
Total Product Life CycleTPLC 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.
-
-