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Terminated

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.

FDA Recall Z-1585-2013 · Posted 2013-06-24

Recalling FirmGE Healthcare It
Recall StatusTerminated
Product CodeJQP
Date Initiated2012-11-20
Date Terminated2016-06-10
Product Quantity9 Units

Reason for Recall

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

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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