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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1

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 Class 2 Recall
Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1
see related information
Date Posted June 24, 2013
Recall Status1 Open
Recall Number Z-1585-2013
Recall Event ID 64789
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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.
Code Information Software Versions 3.3, 4.0, and 4.1
Recalling Firm/
Manufacturer
GE Healthcare It
540 W Northwest Hwy
Barrington, Illinois 60010-3051
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
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.
Quantity in Commerce 9 Units
Distribution Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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