Class 2 Device Recall ACCELERATOR APS System

• Date Initiated by Firm: October 10, 2007
• Date Posted: November 24, 2007
• Recall Status: Terminated on March 10, 2008
• Recall Number: Z-0257-2008
• Recall Event ID: 45429
• Product Classification: Data processing module for clinical use - Product Code JQP
• Product: Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
• Code Information: all serial numbers
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• For Additional Information Contact: 972-518-6154
• Manufacturer Reason for Recall: Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie
• FDA Determined Cause: Software design
• Action: Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.
• Quantity in Commerce: 1 unit.
• Distribution: Nationwide: including state of UT.
• 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.