Aug

2003

Abbott Laboratories HPD/ADD Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Abbott Laboratories HPD/ADD Class II

Amy Sellers

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