FDAFDA · Alimentos y medicamentos·N.º oficial Z-2867-2017
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
Publicado el 9 de agosto de 2017 · Inicio del retiro: 22 de mayo 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
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Sentinel CH SPA
- Distribuidor
- Nationwide Distribution
- Lote
- Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Italy
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