Retiro De Equipo (Recall) de ABX PENTRA Calcium CP Reagent, Model A11A01633

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 Horiba Instruments, Inc dba Horiba Medical.

¿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
    Cresolphthalein complexone, calcium - Product Code CIC
  • Causa
    Horiba medical is informing all pentra 200 and pentra 400 customers of a potential for reporting incorrect calcium results when using the abx pentra calcium cp reagent.
  • Acción
    Horiba Medical sent an Urgent Safety Notice dated September 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter dated September 6, 2013 will be sent to all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent (Reference #: A11A01633) Lot#: 014664503. The recall letter informs the customers that the initial functional tests indicate that there is no interference identified with regards to the patient results. However, with time, there may be an increase in the quantity of precipitates and this could potentially interfere with the performance of this reagent. Customers are informed of the actions to be taken and to complete the customer response form within 10 days. Further questions please call (949) 453-0500 Ext. 208


  • Modelo / Serial
    Lot/Serial #(s): 014664503
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including the country of Canada.
  • Descripción del producto
    ABX PENTRA Calcium CP Reagent, Model # A11A01633 || Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
  • Manufacturer


  • Dirección del fabricante
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Empresa matriz del fabricante (2017)
  • Source