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.
