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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0616-2019

Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

Publicado el 26 de diciembre de 2018 · Inicio del retiro: 16 de octubre de 2018

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

Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Siemens Healthcare Diagnostics, Inc.
Distribuidor
Nationwide/worldwide distribution.
Lote
Dimension Vista software versions 3.7 and 3.8.1
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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