FDAFDA · Alimentos y medicamentos·N.º oficial Z-0101-2017
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.
Publicado el 2 de noviembre de 2016 · Inicio del retiro: 15 de julio de 2016
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
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Roche Diagnostics Operations, Inc.
- Distribuidor
- US Nationwide Distribution
- Lote
- Not applicable
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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