FDAFDA · Alimentos y medicamentos·N.º oficial Z-1994-2013
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
Publicado el 28 de agosto de 2013 · Inicio del retiro: 2 de agosto 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
AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Getinge USA Inc
- Distribuidor
- Worldwide Distribution - USA and the country of Canada.
- Lote
- LOT SR-430 (Expiration 02/06/2014)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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