Events

Retiro De Equipo (Recall) de Device Recall PF4 Concentrated Wash

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 Genetic Testing Institute,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
    70012
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1001-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132110
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Causa
    Some lots of pf4 concentrated wash (10x) are a slightly more dilute concentration. this may lead to slightly increased optical density (od) values. samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
  • Acción
    Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.

Device

Device Recall PF4 Concentrated Wash
  • Modelo / Serial
    Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
  • Descripción del producto
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and || 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) || The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The || PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react || with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic || compounds. The PF4 IgG kit contains all of the reagents necessary to perform || the assay.
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • Dirección del fabricante
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA