FDAFDA · Alimentos y medicamentos·N.º oficial Z-0043-2013
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Publicado el 17 de octubre de 2012 · Inicio del retiro: 10 de agosto 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
It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Immunodiagnostics Systems Ltd
- Distribuidor
- Nationwide Distribution including NY, CA, ME and CT.
- Lote
- Lot 958, EXP Sep 2012
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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