FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
- Recall number
- Z-1142-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
- Status
- Terminated
- Initiated
- 2000-12-29
- Posted
- 2003-08-21
- Terminated
- 2003-08-20
- Reason
- ICT assays run using a manual dilution will not be calculated correctly by the software.
- Root cause
- Other
- Action
- Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
- Quantity
- 143
- Distribution
- Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India
- Lot, serial or model codes
- All units
- 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