Events

Retiro De Equipo (Recall) de Device Recall BD GeneOhm MRSA

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 BD Diagnostics (GeneOhm Sciences, 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
    49470
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0226-2009
  • Fecha de inicio del evento
    2008-07-21
  • Fecha de publicación del evento
    2008-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73505
  • 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
    Assay - Product Code NQX
  • Causa
    Bd diagnostics geneohm (bddg) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant staphylococcus aureus. the potential health hazard related to a false positive result from this assay would be that a patient may be misclassified as having mrsa colonization when in fact they do not have.
  • Acción
    BD Diagnostics GeneOhm (BDDG) initial recall notification was made on 07/21/2008 by telephone and followed up with written notification on 07/22/2008. Domestic customers were advised to check their stock to determine if they have inventory remaining of the recalled lot. If so, BD GeneOhm Technical Service will arrange for return of unused product from the customer. The were provided with a Recall Verification form to complete and return. The customers were instructed if they have remaining tests from the affected referenced lot, please discontinue use immediately. They were also told that BD GeneOhm recommend that they review the results of samples tested using this lot of product. Look for any trends outside of the normal expected results, including any changes in MRSA positivity rates compared to your normal prevalence. If they have any questions or concerns following the review, please contact BDDG Technical Service to arrange for consultation with our Medical Director. An telephone number 1-858-334-6356 was given for customers to contact BDDG Technical Service.

Device

Device Recall BD GeneOhm MRSA
  • Modelo / Serial
    Lot 03T08099 and 03T08099a
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium
  • Descripción del producto
    BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
  • Manufacturer
    BD Diagnostics (GeneOhm Sciences, Inc)

Manufacturer

BD Diagnostics (GeneOhm Sciences, Inc)
  • Dirección del fabricante
    BD Diagnostics (GeneOhm Sciences, Inc), 6146 Nancy Ridge Dr, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA