FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0257-2008
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2007-10-10
- Posted
- 2007-11-24
- Terminated
- 2008-03-10
- 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.
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28