Company: Abbott Laboratories, Inc
Date of Enforcement Report: 3/24/02
Class: II
PRODUCT
AEROSET System Software v1.00ER005.2 and v1.0ER005
Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2.
REASON
System may incorrectly associate sample ID & test requests undercertain conditions of non-bar coded or unreadable bar coded samples.
CODE
All Codes are affected by this field correction.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter dated December 7, 2001.
Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
535.
DISTRIBUTION
Nationwide and Internationally.
