27
Nov
2013

Cl II GE Centricity Laboratory System

0

Company: GE Healthcare It
Date of Enforcement Report: 11/27/2013
Class lI:

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 Recall Number Z-0330-2014

REASON
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 master panel is blank instead of null or the panitem specimen group field of one or more of the ordered items on another re-route master panel on the same request is blank instead of null, and; 3) The re-routed batches containing the affected master panels are recieved at the performing lab before the item causing the reflex is resulted.

RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 3/12/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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