GE Healthcare It: 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

Recalling firm

GE Healthcare It

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

Status

Terminated

Initiated

2013-03-12

Posted

2013-11-15

Terminated

2016-06-10

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 ma

Root 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

7 units

Distribution

Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.

Lot, serial or model codes

Software Versions: 3.3, 4.0, 4.1

510(k) numbers

not on file

PMA numbers

not on file

Product code

JQP

Firm FEI

3004526608

Firm city

Barrington

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy