FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: AEROSET System Software version 1.02ER000
- Recall number
- Z-0091-04
- Recalling firm
- Abbott Laboratories, Inc
- Product
- AEROSET System Software version 1.02ER000
- Status
- Terminated
- Initiated
- 2003-09-30
- Posted
- 2004-07-20
- Terminated
- 2004-04-07
- Reason
- Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
- Root cause
- Other
- Action
- The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
- Quantity
- 133
- Distribution
- Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China
- Lot, serial or model codes
- Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit
- 510(k) numbers
- ["K980367"]
- 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