Device Recall AxSYM

List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC

AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain

AFP Control Kit distributed under the following label: || AxSYM and IMx, Abbott Laboratories USA, North || Chicago, IL 60064

list 5F51-20, lots 01724M300, 03314HN00, 03533HN00

Clinical Chemistry and Clinical Toxicology Devices

2

No

Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.

AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA

All Serial Numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, Greece, Italy, Poland, South Africa, Sweden, United Arab Emirates, Malaysia, Singapore, Hong Kong, Australia, New Zealand, China, Uruguay, Korea, England, Czech Republic, Finland, Hungary, Netherlands, Portugal, Eastern Europe, Switzerland, Central America, and Pakistan

AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas

all lots

Immunology and Microbiology Devices

2

No

Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.

AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064