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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott AxSYM AFP

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  Class 2 Device Recall Abbott AxSYM AFP see related information
Date Initiated by Firm June 12, 2003
Date Posted July 24, 2003
Recall Status1 Terminated 3 on November 21, 2003
Recall Number Z-1047-03
Recall Event ID 26530
PMA Number P820060S011 
Product Classification Kit, Test, Alpha-Fetoprotein For Neural Tube Defects - Product Code LOK
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)
Code Information 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.
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Customer Support Center
877-422-2688
Manufacturer 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 Determined
Cause 2		 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
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 = LOK and Original Applicant = Abbott Laboratories
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