Events

Retiro De Equipo (Recall) de Device Recall InflammaDry

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 Quidel 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
    77640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2803-2017
  • Fecha de inicio del evento
    2017-06-22
  • 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=157032
  • 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
    MMP-9 test system - Product Code PFQ
  • Causa
    In-house testing revealed the presence of plastic spurs at the tips of some sample collectors.
  • Acción
    Quidel sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected customers. The notice instructed consignees to check inventory for affected lots (11705359 and 1705405), to remove and destroy any affected sample collectors from affected kits, and complete and return the attached Inventory Assessment/Certificate of Destruction form to Quidel by fax at 858-552-7905 or email to technicalsupport@quidel.com. Any questions by consignees should be directed to Quidel's Technical Support Team at 800-874-1517 or 858-552-1100, or by email at technicalsupport@quidel.com. It is requested that consignees keep recall notification and response in their records.

Device

Device Recall InflammaDry
  • Modelo / Serial
    Lot numbers: 1705405, 1705359
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.
  • Descripción del producto
    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors || InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Dirección del fabricante
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Empresa matriz del fabricante (2017)
    Quidel Corporation
  • Source
    USFDA