Company: GE Healthcare IT
Date of Enforcement Report 12/1/2010
Class ll:

PRODUCT
GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used 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-0123-2011

REASON
Instrument may incorrectly report the result of an antimicrobial sensitivity test.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare IT, Barrington, IL, by letters dated August 27, 2010.
Manufacturer: Triple G Systems Group, Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
22 units

DISTRIBUTION
GA, MI, MN, NY, OH, OR, TN, TX, Australia, Canada, England, India, New Zealand, Qatar, and Scotland