Retiro De Equipo (Recall) de Device Recall HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Product 811909

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 Hach Co.

¿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
    48613
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2352-2008
  • Fecha de inicio del evento
    2008-05-23
  • Fecha de publicación del evento
    2008-09-21
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-20
  • Fuente del evento
    USFDA
  • 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
    Reagent strips - Product Code FKP
  • Causa
    Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results.
  • Acción
    The firm initiated phone calls on 5/22/08 and explained the reason for recall and requested the product be quarantined. The customer was informed they would receive a recall letter providing instructions for return, replacement, or credit. During the phone call, some of the customers asked if they should recall to the end user level and they were told to do so, but this instruction was not verbally given to everyone. The recalling firm issued a letter dated 5/23/08 via overnight mail which explained the reason for recall and requested return of the product. The letter requests the customer to notify the end users. A Return Form was enclosed to report the amount of product being returned. The firm telephoned all nonresponders on 7/1-2/08 to assure they received the recall notification. On 7/21/08, the firm issued two different letters flagged as "Expanded Recall Notification" dated 7/21/08. One of the letters covered Product/Part numbers 811909, 812144, and 821972, which were all HACH brands. The other letter covered Product/Part number 812004, which was a private brand. Reason for recall expansion was explained and return of product was requested. If the product was further distributed, subrecall was requested to the end user level. A "Return Form" was enclosed to be completed to indicate the amount of product being returned. Some customers who tried to order product #811909 received a letter dated 7/28/08 informing them they could use their Total Chlorine DPD Test Kit, product #811902, as an alternative method for testing. For assistance, contact Hach Customer Service at 1-800-548-4381, ext. 3563.

Device

  • Modelo / Serial
    Lot numbers 6248, 6254, 6264, 6266, 6280, 6305, 6312, 6317, 6334, 6347, 6353, 6355, 7002, 7012, 7015, 7031, 7044, 7066, 7072, 7073, 7085, 7094, 7121, 7131, 7049, 7150, 7152, 7163, 7167, 7177, 7295, 7296, 7309, 7325, 7340, 7352, 7355, 8028, 8045, 8066, 8084, 8094, 8106, 8123, 8144, 8155, 8166, 8171, 7179, 7200, 7220, 7236, 7239, 7250, and 7282
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Foreign distribution to Canada and Denmark.
  • Descripción del producto
    HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Hach Co, 100 Dayton Ave, Ames IA 50010-6402
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA