Devices

Device Recall Abbott AxSYM AFP

Model / Serial
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.
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
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
Product Description
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)
Manufacturer
Abbott Laboratories HPD/ADD
1 Event
- Recall of Device Recall Abbott AxSYM AFP

Manufacturer

Abbott Laboratories HPD/ADD

Manufacturer Address
Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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