FDAFDA · Alimentos y medicamentos·N.º oficial Z-1540-2014
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
Publicado el 14 de mayo de 2014 · Inicio del retiro: 20 de marzo de 2014
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
These lots may not recover within range when tested using certain commercially available controls.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Alere San Diego, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
- Lote
- Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.