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FDAFDA · Food and drugs·Recall number Z-0330-2014

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

Published November 27, 2013 · Recall initiated: March 12, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare It
Distributor
Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
Lot
Software Versions: 3.3, 4.0, 4.1
Risk classification
Class II
Area (FDA)
device
Country
United States

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