Sendx Medical Inc

Model Number: 393-841 all serial numbers are affected.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH

ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 || Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI || The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Lot Number 17323

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.

ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.

Clinical Chemistry and Clinical Toxicology Devices

2

No

In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom

ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863

All analyzers produced between 10/26/06 to 3/15/07 are being recalled (serial code/lot code range of 300101 to 300517)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Class II Recall - Worldwide Distribution --- USA including state of Ohio, and countries of Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, The Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, New Zealand, Canada, and Denmark.

ABL80 FLEX Analyzer, Model #393-839