Class 2 Device Recall AxSYM, IMx

• Date Initiated by Firm: December 13, 2002
• Date Posted: March 06, 2003
• Recall Status: Terminated 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/ Manufacturer: Abbott Health Products, Inc.; Hwy 2 Km 58.0; Barceloneta PR 00617
• For Additional Information Contact: Nydia i. Cancel; 787-846-8256
• Manufacturer Reason for Recall: Results lower than package insert ranges
• FDA Determined Cause: Other
• 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.