Company: Abbott Laboratories, Inc.
Date of Enforcement Report: 4/28/04
Class: II
PRODUCT
ARCHTECT System RS-232 Manual, product list number 06F71-
04, for the ARCHITECT i2000 Processing Module and the
ARCHITECT C8000 Processing Module. Recall # Z-0818-04.
REASON
When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
CODE
The RS-232 Manual is not controlled by control or lot numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on March 23, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
101.
DISTRIBUTION
Nationwide and Internationally.
