Recall Z-2671-2016— GE Healthcare It

Class II FDA medical device recall by GE Healthcare It, initiated 2012-11-20, terminated 2017-12-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

GE Healthcare It

Classification

Class II

Status

Terminated

Initiated

2012-11-20

Terminated

2017-12-29

Firm location

Barrington, IL, United States

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