FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
- Recall number
- Z-1218-03
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
- Status
- Terminated
- Initiated
- 2003-08-22
- Posted
- 2003-09-11
- Terminated
- 2004-07-20
- Reason
- There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
- Root cause
- Other
- Action
- Recall letters dated 8/22/03 informed users of the kit to kit difference within the lots, and outlined the actions needed to take for patient results obtained from the use of the affected kits. The customers were requested to destroy any remaining inventory of the affected reagents. Any questions were directed to Abbott's Customer Service at 1-877-422-2688.
- Quantity
- 3505 kits
- Distribution
- Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
- Lot, serial or model codes
- list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
- 510(k) numbers
- ["K992858"]
- PMA numbers
- not on file
- Product code
- LPS
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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