Clinical Chemistry Phenobarbital, list number 1E08
Publicado el 24 de abril de 2013 · Inicio del retiro: 16 de noviembre de 2012
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
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Abbott Laboratories, Inc
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
- Lote
- Lot Numbers 52803UN12, 62299UN12, and 85773UN12
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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