Date Initiated by Firm |
January 29, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 29, 2004 |
Recall Number |
Z-0764-04 |
Recall Event ID |
28391 |
Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
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Product |
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).
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact |
Blair Harvey 201-847-6324
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Manufacturer Reason for Recall |
39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
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FDA Determined Cause 2 |
Other |
Action |
Trade and health care professionals were sent recalled letters dated 1/29/2004. |
Quantity in Commerce |
207092 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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