FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
- Recall number
- Z-0274-04
- Recalling firm
- Abbott Laboratories, Inc
- Product
- The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
- Status
- Terminated
- Initiated
- 2003-10-29
- Posted
- 2003-12-25
- Terminated
- 2007-11-13
- Reason
- Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
- Root cause
- Other
- Action
- All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
- Quantity
- 17,850
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers
- 510(k) numbers
- ["K974651"]
- 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