Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 5/20/2009
Class:ll

PRODUCT
Centricity TriWin Laboratory Information System; The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-1397-2009

REASON
A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated November 17, 2008.
Manufacturer: Triple G Systems Group, Inc. Markham, Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
26 units

DISTRIBUTION
Nationwide and Canada