• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostica Stago Inc.

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


New Search Back to Search Results
 Class 2 Recall
Diagnostica Stago Inc.
see related information
Date Posted March 14, 2013
Recall Status1 Terminated on July 19, 2013
Recall Number Z-0951-2013
Recall Event ID 64320
Premarket Notification
510(K) Number
K962675 
Product Classification Plasma, Coagulation Factor Deficient - Product Code GJT
Product Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asni®res sur Seine (France) Coagulation Assay
Code Information Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01
Recalling Firm/
Manufacturer
Diagnostica Stago, Inc.
5 Century Dr
Parsippany, New Jersey 07054-4607
For Additional Information Contact Stago Hotline
800-725-0607
Manufacturer Reason
for Recall
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.
Quantity in Commerce 2901 kits
Distribution Worldwide Distribution - USA and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GJT and Original Applicant = AMERICAN BIOPRODUCTS CO.
-
-