Events

Retiro De Equipo (Recall) de Sure Check hCG Cassette Pregnancy Test

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 Chembio Diagnostic System 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
    30288
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0277-05
  • Fecha de inicio del evento
    2004-10-06
  • Fecha de publicación del evento
    2004-12-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35617
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Causa
    Poor sealing of pouches and degradation of products. firm received an e-mail from a distributor of an increase in complaints. in response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. chembio's investigation revealed invalid results (no control lines) and some false negatives.
  • Acción
    Recall letters on 10/6/04, followed by a second letter on/about 10/20/04. Recall letters mailed on 11/9/04 to cover recall expansion for 4 additional lots.

Device

Sure Check hCG Cassette Pregnancy Test
  • Modelo / Serial
    Lot U040904 (Exp. 30 SEP 06) ; Recall Expansion: lot U032904/1 (Exp. 30 AUG 06 - 14,364 units distributed)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributors in KS, TN, NC, MA, NY, KY, FL, NV, and Puerto Rico for further distribution to their retail customers. Products also distributed to accounts in Barbados WI, Israel, Costa Rica and Canada.
  • Descripción del producto
    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti-¿ hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
  • Manufacturer
    Chembio Diagnostic System Inc

Manufacturer

Chembio Diagnostic System Inc
  • Dirección del fabricante
    Chembio Diagnostic System Inc, 3661 Horseblock Road, Medford NY 11763-2215
  • Source
    USFDA