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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2671-2016

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.

Publicado el 7 de septiembre de 2016 · Inicio del retiro: 20 de noviembre de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare It
Distribuidor
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
Lote
Versions 4.1, 4.0, 3.3.2 & 3.3Almp
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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