ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Publicado el 3 de junio de 2020 · Inicio del retiro: 21 de noviembre de 2019
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
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Radiometer Medical ApS
- Distribuidor
- Worldwide distribution - US Nationwide. Also distributed OUS.
- Lote
- ABL90 FLEX Model no. 393-090: R0659 - R0977 and Spare Part Hemolyzer Units (902-980): R0526 - R0941
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Denmark
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