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.
