Events

Retiro De Equipo (Recall) de The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. || US Market BD Blood Glucose Monitoring System kit catalog Numbers: || 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); || 322050 (BD Latitude Diabetes Management System); || 322051 (BD Logic Blood Glucose Monitor); || 32205175 ( BD Logic Blood Glucose Monitor); || 322200 (Paradigm Link Blood Glucose Monitor - clear); || 322201 ( Paradigm Link Blood Glucose Monitor - smoke); || 322202 (Paradigm Link Blood Glucose Monitor - blue); || 322203 (Paradigm Link Blood Glucose Monitor - purple). || Canadian market BD Blood Glucose Monitoring System kit catalog numbers: || 322000 (BD Latitude Diabetes Management System); || 322001 (BD Logic Blood Glucose Monitor).

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 Becton Dickinson & Company.

¿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
    28391
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0764-04
  • Fecha de inicio del evento
    2004-01-29
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31801
  • 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
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Causa
    39 lots of bd test strip may produce an increased frequency of e-3 messages when used during blood glucose testing.
  • Acción
    Trade and health care professionals were sent recalled letters dated 1/29/2004.

Device

The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dic...
  • Modelo / Serial
    US Market BD Logic Lot Numbers: 2057320; 2057325; 2507327; 2057361; 2064338; 2064339; 2064341; 2071322; 2071351; 2078324; 2078326; 2078351; 2085324; 2085339; 2085351; 2085360; 2092322; 2092341; 2099322; 2099360; 2106325; 2113325; 3057022; 3057136; 3057147; 3064143; 3064147; 3064148; 3071015; 3071122; 3071125; 3071127; 3071170; 3078023; 3078037; 3078126; 3078135; 3078136; 3078141; 3078142; 3078174; 3085127; 3085139; 3085142; 3085149; 3085161; 3085174; 3092021; 3092122; 3092147; 3092174; 3092176; 3092177; 3099020; 3099147; 3099153; 3099171; 3099174; 3099176; 3099178; 3106147; 3106162; 3113141; 3120176; 3127176.  US Market BD Latitude Lot Numbers: 2057360; 2064360; 2071352; 2078352; 2078353; 2085353; 2092354; 2092360; 2099354; 2099357; 2106357; 2113357; 3057020; 3057021; 3057052; 3064021; 3064055; 3064056; 3064064; 3071021; 3071064; 3085090; 3092106; 3106022.  US Market Paradigm Link Blood Glucose Monitors Lot Numbers (co-Branded BD Logic): 3057049; 3057051; 3057055; 3057056; 3057058; 3057063; 3057064; 3057070; 3057071; 3057073; 3057098; 3057115; 3057120; 3064045; 3064058; 3064059; 3064077; 3064091; 3064097; 3071049; 3071056; 3071072; 3071076; 3071078; 3071080; 3071090; 3071104; 3071112; 3071120; 3078044; 3078045; 3078051; 3078064; 3078069; 3078077; 3078090; 3078101; 3078106; 3085055; 3085056; 3085079; 3085092; 3085093; 3085105; 3085106; 3085108; 3092044; 3092069; 3092085; 3092101; 3092104; 3099055; 3099083; 3099101; 3099108; 3099125; 3106072; 3106078; 3106097; 3106100; 3106118; 3113042; 3113069; 3113107; 3120104; 3127055; 3127056; 3127059; 3127076; 3134090; 3134107; 3141069; 3141112; 3155100.  US Market Paradigm Link (clear) Lot Numbers: 3057199; 3064189; 3064246; 3071178; 3085198; 3085281; 3085282; 3092188; 3120177.  US Market Paradigm Link (smoke) Lot Numbers: 3057183; 3057184; 3057197; 3057198; 3057227; 3057241; 3064204; 3064255; 3064267; 3071196; 3071199; 3071203; 3071245; 3071255; 3078202; 3085184; 3085287; 3092287.  US Market Paradigm Link (Blue) Lot Numbers: 3057189; 3057195; 3057233; 3064196; 3064197; 3064262; 3071232; 3071289; 3078196; 3078294; 3085181; 3085188; 3085261; 3085293; 3113178; 3113182.  US Market Paradigm Link (purple) Lot Numbers: 3057188; 3057196; 3057280; 3064192; 3064195; 3071205; 3071279; 3078184; 3078204; 3078232.  Canadian BD Latitude Lot Numbers: 3057041; 3057042; 3057043.  Canadian BD Logic Lot Numbers: 3057203; 3057205; 3057224; 3057234; 3064199; 3064203; 3064205; 3064224; 3071202; 3071204; 3071237; 3078198; 3078199; 3078205; 3085202; 3099204; 3120198.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped nationwide to 28 Wholesalers, 15 retail pharmacies and pharmacy chains, 18 managed markets/Mail order facilities, and 616 health care professionals. There are 29 Canadian consignees.
  • Descripción del producto
    The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. || US Market BD Blood Glucose Monitoring System kit catalog Numbers: || 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); || 322050 (BD Latitude Diabetes Management System); || 322051 (BD Logic Blood Glucose Monitor); || 32205175 ( BD Logic Blood Glucose Monitor); || 322200 (Paradigm Link Blood Glucose Monitor - clear); || 322201 ( Paradigm Link Blood Glucose Monitor - smoke); || 322202 (Paradigm Link Blood Glucose Monitor - blue); || 322203 (Paradigm Link Blood Glucose Monitor - purple). || Canadian market BD Blood Glucose Monitoring System kit catalog numbers: || 322000 (BD Latitude Diabetes Management System); || 322001 (BD Logic Blood Glucose Monitor).
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Dirección del fabricante
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA