FDAFDA · Alimentos y medicamentos·N.º oficial Z-3135-2017
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Publicado el 27 de septiembre de 2017 · Inicio del retiro: 21 de agosto de 2017
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 identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
- Lote
- All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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