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U.S. Department of Health and Human Services

Class 2 Device Recall ACCELERATOR Device Manager (ADM)

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  Class 2 Device Recall ACCELERATOR Device Manager (ADM) see related information
Date Initiated by Firm October 25, 2007
Date Posted January 25, 2008
Recall Status1 Terminated 3 on April 01, 2008
Recall Number Z-0551-2008
Recall Event ID 45873
Product Classification Calculator/Data Processing Module for Clinical Use - Product Code JQP
Product Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
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/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the
FDA Determined
Cause 2		 Software design
Action Firm notified consignees via Product Correction, Immediate Action Required letter(s) on 10/25/07. Consignees were notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.
Quantity in Commerce 19 units.
Distribution Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.
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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