Events

Retiro De Equipo (Recall) de Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Perkinelmer.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63771
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0686-2013
  • Fecha de inicio del evento
    2012-11-26
  • Fecha de publicación del evento
    2013-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115038
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine - Product Code JNB
  • Causa
    Truncated v-bottomed microplate wells used in assays contain defective wells.
  • Acción
    Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.

Device

Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
  • Modelo / Serial
    Lot Numbers: 617341, 619236
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    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.
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Dirección del fabricante
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA