Company:GE Healthcare IT,
Date of Enforcement Report 6/22/2011
Class ll:
PRODUCT
GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software. The Centricity Laboratory 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. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results. Recall # Z-2563-2011
REASON
The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted..
RECALLING FIRM/MANUFACTURER
GE Healthcare IT, Barrington, IL, by letter dated May 3, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide, Canada, England, and Qatar
