Company: Abbott Laboratories, Inc
Date of Enforcement Report: 11/19/03
Class: II

PRODUCT
AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04.

REASON
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

CODE
Version 1.02ER000 and Version 1.02ER000 Upgrade Kit.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 30, 2003. Firm initiated the recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
133.

DISTRIBUTION
Nationwide and Internationally.