FDAFDA · Alimentos y medicamentos·N.º oficial Z-0815-2016
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
Publicado el 24 de febrero de 2016 · Inicio del retiro: 18 de enero de 2016
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
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Lab Vision Corporation
- Distribuidor
- Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
- Lote
- Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016. Product code: RB368-R1, Lot Number 368R1407B.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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