Retiro De Equipo (Recall) de Device Recall VARIANT II TURBO Link Hemoglobin A1c Program

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 Bio-Rad Laboratories, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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, glycosylated hemoglobin - Product Code LCP
  • Causa
    The elution buffer b, lot no. ga 10430, was shipped in a 2.0 l bottle instead of the standard 2.5 l bottle.
  • Acción
    The firm, BIO-RAD, sent a "Medical Device Correction" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replacement Elution Buffer B. In addition, the customers were to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, Attention: BIO-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad office or 510-724-7000.


  • Modelo / Serial
    Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
  • Descripción del producto
    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. || Calibrator/Diluent Set. || IVD. || Kit components: || Elution Buffer A, 2 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; || CD-ROM - || Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water || Whole Blood Primer, 6 x 1 mL || Sample Vials, 2 x 100 || Instruction Manual. || Bio-Rad Laboratories Inc. Hercules, CA 94547 || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
  • Manufacturer


  • Dirección del fabricante
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Empresa matriz del fabricante (2017)
  • Source