FDAFDA · Alimentos y medicamentos·N.º oficial Z-2414-2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Publicado el 31 de julio de 2024 · Inicio del retiro: 4 de junio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter, Inc.
- Distribuidor
- Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
- Lote
- Serial numbers: 300117, 300116, 300137, 300138, 300139, 300129, 300141, 300143, 300142, 300151, 300152, 300128, 300156, 300153, 300154, 300135, 300164, 300180, 300155, 300167, 300166, 300158, 300171, 300179, 300169, 300182, 300176, 300183, 300198, 300192, 300133, 300188, 300161, 300134, 300190, 300209, 300212, 300211, 300149, 300148, 300150, 300130, 300172, 300197, 300160, 300189, 300170, 300181, 300195, 300194, 300224, 300222, 300168, 300210, 300233, 300207, 300205, 300221, 300203, 300240, 300199, 300200, 300136, 300196, 300178, 300220, 300208, 300126, 300213, 300206, 300219, 300214, 300217, 300215, 300229, 300255, 300257, 300202, 300254, 300223, 300258, 300259, 300218, 300201, 300234, 300237, 300249, 300260, 300238, 300243, 300261, 300231, 300191, 300131, 300236, 300264, 300263, 300193, 300239, 300230, 300235, 300245, 300216, 300247, 300242, 300226, 300270, 300271, 300269, 300174, 300251, 300241, 300232, 300204, 300227, 300228, 300256, 300266, 300281, 300282, 300253, 300244, 300272, 300246, 300145, 300123, 300147, 300297, 300157, 300275, 300284, 300286, 300248, 300273, 300252, 300144, 300146, 300165, 300177, 300173, 300250, 300268, and 300140; UDI-DI 15099590732103.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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