Device Recall AEROSET

Version 1.00ER005 Catalog Number 2-89996-01 and Version 1.00ER005.2 Catalog Number 2-89996-02  AEROSET System software is not controlled by Control or Lot numbers.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland

AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand

AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.

All units on the market prior to 12/3/2001.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England

Aeroset Analyzer, item 9D05-01

Product List Number 9D61-01, no lot numbers or codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand

AEROSET System External Waste Pump

All units

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas