Class 2 Device Recall Centricity Laboratory System

• Date Initiated by Firm: March 12, 2013
• Date Posted: January 02, 2014
• Recall Status: Terminated on June 10, 2016
• Recall Number: Z-0620-2014
• Recall Event ID: 64807
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product 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 also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
• Code Information: Software Versions: 3.3, 4.0, 4.1
• Recalling Firm/ Manufacturer: GE Healthcare It; 540 W Northwest Hwy; Barrington IL 60010-3051
• For Additional Information Contact: 847-589-8496
• Manufacturer Reason for Recall: GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
• FDA Determined Cause: Device Design
• Action: GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers. The letter notified customers of the problem, suggested that customers experiencing this problem should retransmit the result from the instrument once the order exists in iNET and verify that the item level free-text is present in iNET, and to contact their GE service representative to request or install the updated software. Customers with additional questions can contact the GE Healthcare IT Help Desk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-589-8496.
• Quantity in Commerce: 5 units
• Distribution: Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.