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)
This recall has been terminated (originally issued July 24, 2003).
- Company
- Abbott Laboratories Hpd/Add
- Recall Initiated
- June 12, 2003
- Posted
- July 24, 2003
- Terminated
- November 21, 2003
- Recall Number
- Z-1047-03
- Quantity
- 23,000 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
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
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.