FDAFDA · Alimentos y medicamentos·N.º oficial Z-2362-2026
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
Publicado el 17 de junio de 2026 · Inicio del retiro: 16 de abril de 2026
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
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- The Binding Site Group, Ltd.
- Distribuidor
- US Nationwide distribution.
- Lote
- Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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