UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Publicado el 31 de octubre de 2012 · Inicio del retiro: 3 de septiembre 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
Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey
- Lote
- Part Number B12218. Serial numbers 2329, 5477, 5479.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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