GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. 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.
FDA Recall Z-2563-2011 · Posted 2011-06-14
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Recalling FirmGe Healthcare It
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-05-03
Date Terminated2011-10-04
Product Quantity14 units
Reason for Recall
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.
Firm Action
GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 3, 2011 to all affected customers. The letter describes the product, problem, and action to be taken by the customer. The letter provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780.
Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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