Recall Z-1218-03 ยท LPS Urinary Homocystine (Nonquantitative) Test System
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
| Date | Sep 11, 2003 (initiated Aug 22, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992858 | ABBOTT AXSYM HOMOCYSTEINE Abbott Laboratories, Oct 25, 1999 |