Class 3 Device Recall Centricity Laboratory Core Lab

• Date Initiated by Firm: November 20, 2012
• Date Posted: January 29, 2014
• Recall Status: Terminated on May 16, 2016
• Recall Number: Z-0865-2014
• Recall Event ID: 64795
• 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: GE Helpdesk: North America; 847-589-8496
• Manufacturer Reason for Recall: GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc
• FDA Determined Cause: Software design
• Action: An URGENT MEDICAL DEVICE CORRECTION letter date March 12, 2013 was sent to customers. The letter requests that customers review all calculated results to determine if either of the scenarios could occur at their site. If a customer determines that either of the scenarios proposed in the letter could occur at their site, the customer can contact their GE service representative to request or install the software update. Customers with questions can contact the GE Healthcare IT Helpdesk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com.
• Quantity in Commerce: 7 units
• Distribution: Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: 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.