Events

Retiro De Equipo (Recall) de Device Recall Oral Fluid Drug Screen

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 Alere San Diego, 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
    66870
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0653-2014
  • Fecha de inicio del evento
    2013-06-03
  • Fecha de publicación del evento
    2014-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123825
  • 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
    Oral Fluid Drug Screen Device - Product Code DKZ
  • Causa
    Alere initiated this recall of certain lots of the oral fluid drug screen device because the sponge may become dislodged from the saliva collector handle prior to or during the oral fluid sample collection process. if the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
  • Acción
    Firm sent customers notification letter via combination of fax, email or direct mail. The notification letter dated June 3, 2013, titled "URGENT PRODUCT SAFETY NOTICE", informed customers of the recall, reason for recall, product description with lot codes, potential hazard statement, customer required actions, and contact information.

Device

Device Recall Oral Fluid Drug Screen
  • Modelo / Serial
    Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099)  DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420. DSD-765-011 (Alere PN 4080350099)  DOA2100672, DOA2120094, DOA2120095, DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565, DOA3020557. DSF-765-031 (Alere PN 4584150099)  DOA2100438, DOA2100667, DOA2110073, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164)  DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211)  DOA2100614.  Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution: including states of: AL, CA, PA, and VA.
  • Descripción del producto
    Product Brand Name(s): || Innovacon Oral Fluid Drug Screen Device, || OrALert Oral Fluid Drug Screen Device, || OrALert Oral Fluid Drug Screen Device with BZO, || Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. || Type of Packaging: 25 individually pouched test devices & collectors in a labeled || kit box. || The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an || immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid || specimen compete against their respective drug conjugates for binding sites on their specific antibody.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA