Events

Retiro De Equipo (Recall) de Device Recall BD Phoenix PMIC107

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 Becton Dickinson & Co..

¿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
    77370
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0171-2018
  • Fecha de inicio del evento
    2017-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155855
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Bd has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin b (imlsb) test contained on lot 7031818 of phoenix panels. the imlsb resistance d-test screen for staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. as the product should not be used when quality control (qc) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform qc testing and uses the panel, there is a potential to incorrectly treat a staphylococcus infection with clindamycin based on the imlsb test result. this issue can be detected 100% of the time when used per package insert instructions with imlsb positive strain s. aureus baa-977.
  • Acción
    URGENT PRODUCT RECALL LETTER (dated May 2017) were sent to customers via a UPS mailing on May 11, 2017. Customers were instructed to discontinue use of the affected lot and discard any remaining product. BD will replace the discarded inventory. Please complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Please complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or e-mail to: BDRC2@bd.com. For further assistance, please contact BD (Customer/Technical) Support at 1-800-638-8663 in the USA.

Device

Device Recall BD Phoenix PMIC107
  • Modelo / Serial
    Lot 7031818, Exp. Date 2/28/2018
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CT, VA, PA, TX, FL, NC, WI, NM
  • Descripción del producto
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. || PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA