FDAFDA · Alimentos y medicamentos·N.º oficial Z-1793-2014
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
Publicado el 25 de junio de 2014 · Inicio del retiro: 17 de abril 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
Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Gen-Probe Inc
- Distribuidor
- Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).
- Lote
- Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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