FDAFDA · Alimentos y medicamentos·N.º oficial Z-1791-2014
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Publicado el 25 de junio de 2014 · Inicio del retiro: 21 de mayo de 2014
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
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Roche Diagnostics Operations, Inc.
- Distribuidor
- US Nationwide Distribution
- Lote
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- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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