Company:Abbott Laboratories, Inc
Date of Enforcement Report:12/19/2007
Class:ll
PRODUCT
a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-
01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and
v3.10, Recall $ Z-0146-2008;
b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number
3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60,
v3.00 and v3.10, Recall # Z-0147-2008
REASON
Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letters on September 17, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,159 units
DISTRIBUTION
Nationwide and Internationally
