Events

Retiro De Equipo (Recall) de Device Recall T2CandidaCartridges

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 T2 Biosystems 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
    74732
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2795-2016
  • Fecha de inicio del evento
    2016-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148334
  • 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
    Candida species nucleic acid detection system - Product Code PII
  • Causa
    Elevated levels of invalid results.
  • Acción
    Customers were notified of the recall vie e-mail and certified mail on July 7, 2016, with an Urgent Medical Device Recall letter. Customers were asked to take the following actions: 1. Please examine your current inventory and determine whether you have any of the recalled lots listed. (a.) If you DO have cartridges from the recalled lots, please note the quantity of cartridges you have of each lot number on the attached form entitled T2Candida Cartridge Recall Customer Response Form (CRF). Please also immediately quarantine any cartridges from the indicated lots and do not use them. (b.) If you DO NOT have any cartridges from the recalled lots, please also note this in the space provided on the form 2. Send the completed CRF to T2Biosystems via e-mail to orders@t2biosystems.com or via fax to 781-240-0541. Your primary contact at T2 for all recall-related correspondence or questions is Georgette Yannios (gyannios@t2biosystems.com or 877-504-8282 Option 3). All product will be replaced at no charge to you as soon as possible. 3. Once T2 receives the CRF, we will issue a Return Material Authorization (RMA) number to you along with a FedEx shipping label. After you receive this RMA number and label, please follow the instructions provided with the RMA for shipment of cartridges back to T2 (please do not ship reagent trays as they are not subject to this action).

Device

Device Recall T2CandidaCartridges
  • Modelo / Serial
    Lot Numbers:  000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.
  • Descripción del producto
    T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). || A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
  • Manufacturer
    T2 Biosystems Inc

Manufacturer

T2 Biosystems Inc
  • Dirección del fabricante
    T2 Biosystems Inc, 101 Hartwell Ave, Lexington MA 02421-3125
  • Empresa matriz del fabricante (2017)
    T2 Biosystems, Inc.
  • Source
    USFDA