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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
Products Sold
list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
Abbott Laboratories HPD/ADD/GPRD is recalling AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Lab due to There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026