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Terminated

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

FDA Recall Z-0551-2008 · Posted 2008-01-25

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2007-10-25
Date Terminated2008-04-01
Product Quantity19 units.

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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