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

Class 2 Device Recall AXSYM System

  • 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 2 Device Recall AXSYM System see related information
Date Initiated by Firm October 29, 2003
Date Posted December 25, 2003
Recall Status1 Terminated 3 on November 13, 2007
Recall Number Z-0274-04
Recall Event ID 27730
510(K)Number K974651  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Code Information Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
FDA Determined
Cause 2
Other
Action All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
Quantity in Commerce 17,850
Distribution Worldwide
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
-
-