Recall Z-1585-2013— GE Healthcare It

Class II FDA medical device recall by GE Healthcare It, initiated 2012-11-20, terminated 2016-06-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl.

Recalling firm

GE Healthcare It

Classification

Class II

Status

Terminated

Initiated

2012-11-20

Terminated

2016-06-10

Firm location

Barrington, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.