Events

Retiro De Equipo (Recall) de Device Recall API ZYM B (Ref 70493)

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 BioMerieux SA.

¿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
    73060
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0756-2016
  • Fecha de inicio del evento
    2016-01-08
  • Fecha de publicación del evento
    2016-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142938
  • 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
    Device, general purpose, microbiology, diagnostic - Product Code LIB
  • Causa
    Discrepant identification results related to api identification strips. these discrepant identification results are due to false negative results on the tests of the strips linked to the zym b reagent.
  • Acción
    BioM¿rieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their files, and forward the information to all parties that may use the product. For additional assistance or have any questions, contact your local bioM¿rieux Customer Service representative.

Device

Device Recall API ZYM B (Ref 70493)
  • Modelo / Serial
    Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
  • Descripción del producto
    API ZYM Bx2 (Ref 70493) || Product Usage: || ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Dirección del fabricante
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA