Company: Abbott Laboratories HPD/ADD
Date of Enforcement Report: 8/6/03
Class: II
PRODUCT
AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03.
REASON
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%.
CODE
All lots of AFP list 7A48-22 and 7A48-21 used with all lots of AxSYM Cancer Assay Disk list 3D50-02, 3D50-03 and 3D50-04 with AFP Assay File version 2.00.200, when used with AxSYM System Software Versions 3.00 and higher.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated June 12, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23,000 kits.
DISTRIBUTION
Nationwide, and Internationally.
