FDAFDA · Alimentos y medicamentos·N.º oficial Z-1737-2014
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
Publicado el 18 de junio de 2014 · Inicio del retiro: 14 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
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
- Lote
- Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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