Events

Retiro De Equipo (Recall) de Device Recall CellDyn Ruby Hematology Analyzer

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 Abbott Laboratories.

¿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
    51207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1398-2009
  • Fecha de inicio del evento
    2009-02-12
  • Fecha de publicación del evento
    2009-05-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79202
  • 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
    Counter, differential cell - Product Code GKZ
  • Causa
    Burn risk-- when power is cycled to the instrument, there is a possibility that the mixer motor assembly may reach 100 degrees celsius (212 degrees fahrenheit ). if the customer touches the motor, burns may occur.
  • Acción
    A "Product Correction" letter dated February 12, 2009 and "Customer Reply" form were sent to all currently active CELL-DYN Ruby customers using Software Version 2.0 ML. The letter described the affected product, necessary actions and contact information for customers. Customers were instructed to acknowledge receipt of the "Product Correction" letter by completing the enclosed Customer Reply form and return via fax to 1-800-777-0051. A product information letter is being added to the accessory kits shipped with new instruments and version 2.0 ML System Software upgrade kits. For questions regarding this information, contact Abbott Laboratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact your local hematology customer support representative.

Device

Device Recall CellDyn Ruby Hematology Analyzer
  • Modelo / Serial
    Serial Numbers: 34868BG 34047BG 34116BG 34756BG 34012BG 34286BG 34595BG 34596BG 34597BG 34741BG 34920BG 34921BG 34922BG 34150BG 34429BG 34479BG 34518BG 34551BG 34552BG 34846BG 34526BG 34872BG 34873BG 34122BG 34657BG 34087BG 34163BG 34300BG 34537BG 34689BG 34691BG 34692BG 34283BG 34735BG 34111BG 34346BG 34416BG 34767BG 34963BG 34964BG 34965BG 34966BG 34969BG 34973BG 34974BG 34975BG 34976BG 34979BG 34001BG 34003BG 34004BG 34005BG 34010BG 34082BG 34091BG 34098BG 34110BG 34132BG 34191BG 34199BG 34227BG 34229BG 34231BG 34243BG 34324BG 34333BG 34336BG 34337BG 34434BG 34462BG 34503BG 34504BG 34507BG 34535BG 34568BG 34713BG 34733BG 34742BG 34760BG 34761BG RD009 34282BG 34021BG 34138BG 34140BG 34171BG 34384BG 34490BG 34506BG 34529BG 34668BG 34670BG 34736BG 34739BG 34870BG 34887BG 34893BG 34862BG 34863BG 34864BG 34880BG 34886BG 34860BG 34916BG 34917BG 34563BG 34565BG 34698BG 34080BG 34175BG 34247BG 34453BG 34188BG 34832BG 34833BG 34079BG 34123BG 34125BG 34448BG 34942BG 34737BG 34861BG 34907BG 34865BG 34866BG 34867BG 24525BG  34242BG 34261BG 34262BG 34263BG 34265BG 34267BG 34348BG 34353BG 34413BG 34415BG 34722BG 34101BG 34948BG 34310BG 34850BG 34851BG 34852BG 34853BG 34854BG 34855BG 34856BG 34857BG 34858BG 34859BG 34869BG 34871BG 34875BG 34889BG 34892BG 34894BG 34895BG 34896BG 34897BG 34915BG 34918BG 34919BG 34923BG 34924BG 34925BG 34926BG 34927BG 34928BG 34929BG 34930BG 34931BG 34941BG 34943BG 34944BG 34945BG 34946BG 34947BG 34957BG 34073BG 34075BG 34085BG 34088BG 34106BG 34131BG 34135BG 34143BG 34144BG 34146BG 34156BG 34159BG 34161BG 34165BG 34183BG 34192BG 34193BG 34196BG 34200BG 34202BG 34205BG 34206BG 34207BG 34208BG 34255BG 34256BG 34259BG 34299BG 34319BG 34343BG 34379BG 34380BG 34381BG 34383BG 34392BG 34401BG 34403BG 34407BG 34411BG 34423BG 34427BG 34428BG 34430BG 34443BG 34446BG 34447BG 34450BG 34458BG 34461BG 34486BG 34489BG 34513BG 34517BG 34519BG 34520BG 34521BG 34547BG 34549BG 34553BG 34555BG 34556BG 34573BG 34574BG 34575BG 34582BG 34588BG 34601BG 34602BG 34605BG 34612BG 34613BG 34616BG 34626BG 34630BG 34632BG 34654BG 34677BG 34678BG 34681BG 34683BG 34696BG 34699BG 34708BG 34747BG 34749BG 34757BG 34764BG 34772BG 34775BG 34776BG 34777BG 34779BG 34796BG 34797BG 34798BG 34803BG 34810BG 34811BG 34812BG 34814BG 34817BG 34819BG 34820BG and 34847BG.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.
  • Descripción del producto
    Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. || Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA