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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM, IMx

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  Class 2 Device Recall AxSYM, IMx see related information
Date Initiated by Firm December 13, 2002
Date Posted March 06, 2003
Recall Status1 Terminated 3 on June 02, 2004
Recall Number Z-0627-03
Recall Event ID 25554
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AFP Control Kit distributed under the following label:
AxSYM and IMx, Abbott Laboratories USA, North
Chicago, IL 60064
Code Information Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003
Recalling Firm/
Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information Contact Nydia i. Cancel
Manufacturer Reason
for Recall
Results lower than package insert ranges
FDA Determined
Cause 2
Action Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.
Quantity in Commerce 826 kits
Distribution Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
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.