Events

Rappel 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).

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Becton Dickinson & Company.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    28391
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0764-04
  • Date de mise en oeuvre de l'événement
    2004-01-29
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31801
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Cause
    39 lots of bd test strip may produce an increased frequency of e-3 messages when used during blood glucose testing.
  • Action
    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...
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA