FDAFDA · Alimentos y medicamentos·N.º oficial Z-0002-2018
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Publicado el 11 de octubre de 2017 · Inicio del retiro: 23 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
The high control for the kit is recovering low and may be out of range for assigned values.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- The Binding Site Group, Ltd.
- Distribuidor
- Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
- Lote
- Lot #400900, Exp. 12/31/2017, UDI #05051700016421
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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