FDAFDA · Alimentos y medicamentos·N.º oficial Z-0686-2013
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Publicado el 23 de enero de 2013 · Inicio del retiro: 26 de noviembre 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
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Perkinelmer
- Distribuidor
- Nationwide Distribution.
- Lote
- Lot Numbers: 617341, 619236
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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