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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 Device Recall Centricity Laboratory Core Lab Versions 3.3, 4.0, 4.1 see related information
Date Initiated by Firm November 20, 2012
Create Date August 26, 2016
Recall Status1 Terminated 3 on December 29, 2017
Recall Number Z-2671-2016
Recall Event ID 64796
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Centricity Laboratory Core Lab System 4.1

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.
Code Information Versions 4.1, 4.0, 3.3.2 & 3.3Almp
Recalling Firm/
Manufacturer		 GE Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact Jeme Wallace
847-277-5000
Manufacturer Reason
for Recall		 The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.
FDA Determined
Cause 2		 Software design
Action GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071. Customers were instructed to contact their GE Service Representative with any questions regarding this issue. For other questions, contact GE Helpdesk: North America; (905) 479-1249 or 1-888-778-3375; email: tgg.nahelpdesk@med.ge.com Europe; +44 1603 877595; email: tgg.ukhelpdesk@med.ge.com Asia Pacific; +61 3 5327 4000; email: tgg.ozhelpdesk@med.ge.com. For questions regarding this recall call 847-277-5000.
Quantity in Commerce 17
Distribution Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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