Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 6006
FDA device recall Z-0257-2008 · posted 2007-11-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- 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
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 1 unit.
- Distribution
- Nationwide: including state of UT.
- Date initiated
- 2007-10-10
- Date posted
- 2007-11-24
- Date terminated
- 2008-03-10
- Location
- Irving, TX
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