Recall Z-1047-03 ยท LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Abbott Laboratories HPD/ADD
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)
| Date | Jul 24, 2003 (initiated Jun 12, 2003) |
| Status | Terminated |
| Reason | AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5% |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.