ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA

Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.