| Class 2 Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1 |  |
Date Initiated by Firm | November 20, 2012 |
Date Posted | June 24, 2013 |
Recall Status1 |
Terminated 3 on June 10, 2016 |
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 IL 60010-3051
|
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 | Software design |
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 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.
|
|
|
|