AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (V
FDA device recall Z-1047-03 · posted 2003-07-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOK
- Quantity affected
- 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, Col
- Date initiated
- 2003-06-12
- Date posted
- 2003-07-24
- Date terminated
- 2003-11-21
- Location
- Abbott Park, IL
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