Recall Z-0257-2008
Abbott Laboratories, Inc · initiated October 10, 2007
Product
Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
Codes / lots: all serial numbers
Reason for recall
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
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0257-2008
- Initiated
- October 10, 2007
- Posted by FDA
- November 24, 2007
- Terminated
- March 10, 2008
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 1 unit.
- Distribution
- Nationwide: including state of UT.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX