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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0

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  Class 2 Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0 see related information
Date Initiated by Firm February 20, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on August 23, 2010
Recall Number Z-2222-2009
Recall Event ID 51275
PMA Number P820060S008 
Product Classification Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
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).
Code Information List Number 3D50-05, version 5.0
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LOJ and Original Applicant = Abbott Laboratories
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