Z-1047-03

AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list...

Name: Z-1047-03 AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-06-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-06-12 / Terminated

FDA source

Abbott Laboratories HPD/ADD began a recall of 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... on 2003-06-12. The reason FDA records is "AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1047-03
Status: Terminated
Initiated: 2003-06-12
Posted: 2003-07-24
Terminated: 2003-11-21
Recalling firm: Abbott Medical
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)
Product code: LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Reason for recall: AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
FDA root cause: Other
Action: All AxSYM AFP customers were informed not to use the 1:101 automated dilution protocol via Device Correction letter dated 6/12/03. If necessary, manually dilute samples per the AxSYM AFP package insert.
Quantity in commerce: 23,000 kits
Distribution: Nationwide and internationally to Australia, Canada, Costa Rica, Ecuador, Japan, Panama, San Salvador, Thailand, Barbados, Chili, Curacao, Honduras, Korea, Peru, Singapore, United Kingdom, Brazil, Columbia, Dominican Republic, Hong Kong, Pakistan, St. Vincent, Uruguay
Product codes and lots: 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 Sotware Versions 3.00 and higher.

Product code LOK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)