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U.S. Department of Health and Human Services

Class 2 Device Recall ACCELERATOR APS System

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  Class 2 Device Recall ACCELERATOR APS System see related information
Date Initiated by Firm October 10, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 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 2		 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.
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