Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued November 24, 2007).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- October 10, 2007
- Posted
- November 24, 2007
- Terminated
- March 10, 2008
- Recall Number
- Z-0257-2008
- Quantity
- 1 unit.
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide: including state of UT.
Lot / Code Info
all serial numbers
Root 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.