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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1471-2017

VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.

Publicado el 22 de marzo de 2017 · Inicio del retiro: 1 de febrero de 2017

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

Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Ortho-Clinical Diagnostics
Distribuidor
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
Lote
REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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