Company: Abbott Laboratories, Inc
Date of Enforcement Report: 5/21/03
Class: II

PRODUCT
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Recall #Z-0788-03.

REASON
Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.

CODE
All lots.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
645 units.

DISTRIBUTION
Nationwide and Internationally.