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)
FDA Recall Z-1047-03 · Posted 2003-07-24
Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeLOK
Date Initiated2003-06-12
Date Terminated2003-11-21
Product Quantity23,000 kits
Reason for Recall
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.