Recall Z-0551-2008
Abbott Laboratories, Inc · initiated October 25, 2007
Product
Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
Codes / lots: All Serial Numbers.
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: 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.
Details
- Recall number
- Z-0551-2008
- Initiated
- October 25, 2007
- Posted by FDA
- January 25, 2008
- Terminated
- April 1, 2008
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 19 units.
- Distribution
- Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX