Z-2222-2009

Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott...

Name: Z-2222-2009 Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott...
Creator: Abbott Laboratories
Published: 2009-02-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-02-20 / Terminated / root cause: design

FDA source

Abbott Laboratories began a recall of Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05... on 2009-02-20. The reason FDA records is "The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2222-2009
Status: Terminated
Initiated: 2009-02-20
Posted: 2009-09-18
Terminated: 2010-08-23
Recalling firm: Abbott Medical
Product: Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
Product code: LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Reason for recall: The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott sent "Product Correction Immediate Action Required" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.
Quantity in commerce: 8,205 disks
Distribution: Worldwide Distribution -- United States (including Puerto Rico), Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Curacao (Neth Ant), Dominican Republic, Germany, Guatemala, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Trinidad and Tobago, Turks and Caicos and Venezuela.
Product codes and lots: List Number 3D50-05, version 5.0

Product code LOJ

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)