Events

Retiro De Equipo (Recall) de Device Recall Chemistry Wash1 REF 10680

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 Medica Corporation.

¿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
    79264
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1149-2018
  • Fecha de inicio del evento
    2017-11-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161792
  • 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
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • Causa
    The firm has initiated a field recall of the wash1 kit ref 10680 due to reported inconsistent lipase values when analyzing patient samples. the firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (trig) assay if they are on the same worklist.
  • Acción
    Firm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please discuss possible concerns about lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.

Device

Device Recall Chemistry Wash1 REF 10680
  • Modelo / Serial
    Lots 16279, 17045 and 17215
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide and US Distribution.
  • Descripción del producto
    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 || Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
  • Manufacturer
    Medica Corporation

Manufacturer

Medica Corporation
  • Dirección del fabricante
    Medica Corporation, 5 Oak Park Dr, Bedford MA 01730-1430
  • Empresa matriz del fabricante (2017)
    Medica Corporation
  • Source
    USFDA