AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
Hazard
There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
What You Should Do
Remedy
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.
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Products
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
- UPC
- list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
Units Affected
3505 kits