Recall Z-0257-2008 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
| Date | Nov 24, 2007 (initiated Oct 10, 2007) |
| Status | Terminated |
| Reason | Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie |
| Root cause | Software design |
| Action | Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade. |
| Quantity | 1 unit. |
| Distribution | Nationwide: including state of UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.