Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
This recall has been terminated (originally issued January 25, 2008).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- October 25, 2007
- Posted
- January 25, 2008
- Terminated
- April 1, 2008
- Recall Number
- Z-0551-2008
- Quantity
- 19 units.
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.
Lot / Code Info
All Serial Numbers.
Root Cause
Software design
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.