Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

FDA device recall Z-0551-2008 · posted 2008-01-25 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

19 units.

Distribution

Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.

Date initiated

2007-10-25

Date posted

2008-01-25

Date terminated

2008-04-01

Location

Irving, TX