FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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).
- Recall number
- Z-0764-04
- Recalling firm
- Becton Dickinson & Company
- 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).
- Status
- Terminated
- Initiated
- 2004-01-29
- Posted
- 2004-07-20
- Terminated
- 2004-10-29
- Reason
- 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
- Root cause
- Other
- Action
- Trade and health care professionals were sent recalled letters dated 1/29/2004.
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28