FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
- Recall number
- Z-0788-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
- Status
- Terminated
- Initiated
- 2003-02-24
- Posted
- 2003-05-01
- Terminated
- 2004-10-28
- Reason
- Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
- Root cause
- Other
- Action
- A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.
- Quantity
- 645 units
- Distribution
- Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K980367"]
- PMA numbers
- not on file
- Product code
- JJE
- 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