FDAFDA · Alimentos y medicamentos·N.º oficial Z-0612-2013
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
Publicado el 2 de enero de 2013 · Inicio del retiro: 1 de noviembre 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
It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Lote
- Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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