Events

Retiro De Equipo (Recall) de Device Recall May and Grunwald's Stain

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 EMD Chemicals Inc.

¿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
    39354
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0133-2008
  • Fecha de inicio del evento
    2007-07-30
  • Fecha de publicación del evento
    2007-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55274
  • 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
    Hematology Stains - Product Code KQC
  • Causa
    Out of spec -- the batch (lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
  • Acción
    EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.

Device

Device Recall May and Grunwald's Stain
  • Modelo / Serial
    Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was released to 2 distributors; one in the US, one in Canada
  • Descripción del producto
    Harleco || May and Grunwald's Stain; || 0.17% w/v; || Methanol Solution UN1230; || EMD Chemicals Inc. || An Affilifate of Merck KGaA || Damstadt, Germany; || 480 South Democrat Road; || Gibbstown, NJ 08027; || 1 liter and 4 liter poly bottles
  • Manufacturer
    EMD Chemicals Inc

Manufacturer

EMD Chemicals Inc
  • Dirección del fabricante
    EMD Chemicals Inc, 480 S Democrat Rd, Gibbstown NJ 08027-1239
  • Source
    USFDA