AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- August 22, 2003
- Posted
- September 11, 2003
- Terminated
- July 20, 2004
- Recall Number
- Z-1218-03
- Quantity
- 3505 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
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 / Code Info
list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
Root Cause
Other
Action Taken
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.