Company: Abbott Laboratories, Inc.
Date of Enforcement Report:1/25/2006
Class:lI

PRODUCT
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, Recall # Z-0398-06

REASON
System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.

CODE
All lots/serial numbers

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc, Irving, TX, by letter dated December 8, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1206 units

DISTRIBUTION
Nationwide and Internationally