Retiro De Equipo (Recall) de Device Recall D10 Dual Program Reorder Pack

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
    Reports of calibration failure and late retention time using elution buffer aa10434 and aa10435.
  • Acción
    Bio-Rad Laboratories Inc sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected D-10 Dual customers and Bio-Rad subsidiaries on July 11, 2011 via FedEx or fax. The letters identified the product, the problem, and the action needed to be taken. The letters ask that inventory be examined and affected reorder pack lots be quarantined and destroyed according to local, state and federal regulations. All D-10 Dual customers were instructed to review their chromatograms generated from these lots. If the calibration has passed with good chromatography, the controls are within specification, and the F, A1c, and A2 peaks elute in their specified retention time windows for the patient samples, the customer may continue to use and report results with the affected buffer lots. The letters include a chart showing Good Patient Chromatogram with Correct Retention times and Failed Calibrator Chromatogram with late retention times. If calibration fails and/or late retention times cause one or more peaks to be misidentified, affected reorder packs should be destroyed. The correction letters and response form should be translated, if necessary, and distributed to all affected customers. Tracking documentation should be compiled for all customers who receive the Medical Device Correction letter. The Medical Device Correction Response Forms should be completed and returned by fax to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or a PDF copy to


  • Modelo / Serial
    Model number 220-0201; Kit Lot number/Expiration date: 20010663/Sept 2012; 20010665-A/Sept 2012; 20010665-B/Sept 2012; 20010665-C/Sept 2012.  Elution Buffer Lot numbers: AA10434, AA10435; Exp 9/30/2012
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. Korea.
  • Descripción del producto
    D-10 Dual Program Reorder Pack; || contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. || Bio-Rad Laboratories Inc. Hercules, CA. || Product Usage: || Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use.
  • Manufacturer


  • Dirección del fabricante
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source