FDAFDA · Alimentos y medicamentos·N.º oficial Z-0011-2014
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Publicado el 23 de octubre de 2013 · Inicio del retiro: 12 de agosto de 2013
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 determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Healthcare Diagnostics
- Distribuidor
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.
- Lote
- All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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