Events

Retiro De Equipo (Recall) de Device Recall FB Broth

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 Hardy Diagnostics.

¿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
    72786
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0470-2016
  • Fecha de inicio del evento
    2015-11-18
  • Fecha de publicación del evento
    2015-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142209
  • 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
    Culture media, general nutrient broth - Product Code JSC
  • Causa
    The firm is recalling fb broth cat. no. k31, lot no. 15231 because of potential burkholderia fungorum contamination.
  • Acción
    Hardy Diagnostic notified Customers via phone on November 18, 2015, followed up with written notifications being sent via first class, email, or facsimile. Customers were instructed to destroy the recalled product according to local regulations for nonhazardous waste if uninoculated or as medical waste if inoculated. and to discard any remaining tubes of the recalled lot. Any remaining product on hand the firm stated would be replaced. The firm stated to customers that they would follow-up the phone conversation with written communication and requested a full name, and email or fax number. We sincerely apologize for the inconvenience. Thank you in advance for completing the attached form. Please feel free to contact our Technical Services Department if you have not received your replacements or if you have additional questions about this notification. Technical Services can be reached at (800) 266-2222, option 2 or via email at TechService@HardyDiagnostics.com.

Device

Device Recall FB Broth
  • Modelo / Serial
    Cat. no. K31 Lot no.15231
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US. Distribution to the states of : CA, WI, MD and UT. .
  • Descripción del producto
    FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Dirección del fabricante
    Hardy Diagnostics, 1430 W McCoy Ln, Santa Maria CA 93455-1005
  • Empresa matriz del fabricante (2017)
    Hardy Diagnostics
  • Source
    USFDA