Events

Retiro De Equipo (Recall) de Device Recall enGen(TM) Laboratory Automation System

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 Ortho-Clinical 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
    73616
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1569-2016
  • Fecha de inicio del evento
    2016-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144609
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.G., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
  • Acción
    On 3/17/2016 URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2016-074, dated 3/17/2016)) was sent notifying the users of the issue and advise them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Foreign affiliates were informed by email on 3/17/2016 of the issue and instructed to notify their consignees of the issue and required actions.

Device

Device Recall enGen(TM) Laboratory Automation System
  • Modelo / Serial
    US Serial Numbers: JFBX395J, GBX395J, J953252, JJXBQW4J, J3RHC23J, J86PWC5J, J5LQ6Q2J, JFCM073J, J54FC01J, J5J4B45J, J7KSC15J, J4HX7S4J, JGWXQ52J, J953221, JG7BFB5J, JHPKG25J, JCXL941J, J736BM4J, JFXCBG3J; -- Foreign Serial Numbers: J89133 (VAS), JHWJZY4J, J3J4B45J, J953244, JCT20Q3J, J16XQH4J, GWJVY4J, DWX052J,  J271264, J271368, J271371, J271269, J85206, J953216, DP2LF62, J7023874, J7023847, J7025017, J7024893, J7023645, J7023435, J57663, J800103, S/N 89VQ762 (VAS), J75863, J75691, J30372, J3055503, J3055496.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.
  • Descripción del producto
    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA