Events

Retiro De Equipo (Recall) de Device Recall LifeScan

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 Lifescan 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
    32200
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0887-05
  • Fecha de inicio del evento
    2003-11-17
  • Fecha de publicación del evento
    2005-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39361
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Causa
    A control solution range for the onetouch ultra test strip of 111-150 mg/dl was incorrectly labeled as 97-131 mg/dl.
  • Acción
    On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.

Device

Device Recall LifeScan
  • Modelo / Serial
    OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field. The lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only. The recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV. (A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.) The total number of government sales/distribution centers that received the recall product = 0.
  • Descripción del producto
    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., || 1000 Gibraltar Drive, Milpitas, CA 95037
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Dirección del fabricante
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA