Events

Retiro De Equipo (Recall) de Device Recall RPC EZ Chek Sensitive Total Chlorine and Chloramines Test Strips, Product Code K1000106v

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-2354-2008
  • Fecha de inicio del evento
    2008-05-23
  • Fecha de publicación del evento
    2008-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72686
  • 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
    Test 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

Device Recall RPC EZ Chek Sensitive Total Chlorine and Chloramines Test Strips, Product Code K10...
  • Modelo / Serial
    Lot numbers 6265, 6310, 7008, 7054, 7086, 7130, 7183, 7201, 7234, 7284, 7313, 8010, 8030, 8057, 8078, 8108, and 8160
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Foreign distribution to Canada and Denmark.
  • Descripción del producto
    RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays per shipping case, Product code K100-0106 (HACH Part #812004). The label shows the product is Manufactured for Reprocessing Products Corp. (RPC), Minneapolis, MN. 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
    Hach Co

Manufacturer

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