Class 2 Device Recall Centricity Laboratory Core Lab

• Date Initiated by Firm: March 12, 2013
• Date Posted: November 15, 2013
• Recall Status: Terminated on June 10, 2016
• Recall Number: Z-0330-2014
• Recall Event ID: 64806
• 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
• Manufacturer Reason for Recall: GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the ma
• FDA Determined Cause: Software design
• Action: GE Healtchare sent an Urgent Medical Device Correction letter dated March 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers review their workflows to determine whether this series of events could happen at their sites. Customers who self-identified this series of events as a possible workflow are recommended to contact their GE service representative for a software correction. These customers may also elect to identify master panels that may be re-routed ad hoc and then to ensure that the specimen group field is updated to NULL if currently set to blank. Customers with any questions about this issue are advised to contact their GE service representative or the GE Healthcare IT Help Desk: North America at tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-277-4468.
• Quantity in Commerce: 7 units
• Distribution: Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
• 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.