Z-1218-03

AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott...

Name: Z-1218-03 AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-08-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-08-22 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA on 2003-08-22. The reason FDA records is "There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1218-03
Status: Terminated
Initiated: 2003-08-22
Posted: 2003-09-11
Terminated: 2004-07-20
Recalling firm: Abbott Medical
Product: AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
FDA 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 in commerce: 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.
Product codes and lots: list 5F51-20, lots 01724M300, 03314HN00, 03533HN00

Product code LPS

K992858Class IIAbbott Axsym HomocysteineAbbott Laboratories / cleared 1999-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)