Recall Z-0551-2008 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
| Date | Jan 25, 2008 (initiated Oct 25, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 19 units. |
| Distribution | Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.