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

Class 2 Device Recall CELLDYN 3200

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


New Search Back to Search Results
 Class 2 Recall
CELLDYN 3200
see related information
Date Posted April 03, 2007
Recall Status1 Terminated on May 01, 2007
Recall Number Z-0706-2007
Recall Event ID 37453
Premarket Notification
510(K) Number
K972354 
Product Classification Diluent, Blood Cell - Product Code GIF
Product CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Code Information Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2
Recalling Firm/
Manufacturer
Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara, California 95054-1113
Manufacturer Reason
for Recall
Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.
Quantity in Commerce 27,411 units
Distribution Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.
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 = GIF and Original Applicant = ABBOTT LABORATORIES
-
-