FDAFDA · Alimentos y medicamentos·N.º oficial Z-1563-2013
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Publicado el 3 de julio de 2013 · Inicio del retiro: 13 de mayo de 2013
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
It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Microgenics Corporation
- Distribuidor
- Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
- Lote
- Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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