—#31751

Product

BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K022580, K022581, K030531
Affected lot / code info: US Market Lot Numbers: 2064322; 2064333; 2071311; 2078294; 2099353; 2120336; 3057009; 3064013; 3064016; 3064018; 3064030; 3064037; 3064069; 3064076; 3064079; 3064083; 3064090; 3064104; 3064107; 3064112; 3064118; 3064121; 3064125; 3064132; 3064156; 3064167; 3064170; 3064174; 3064182; 3064188; 3064237; 3064245; 3064279; 3071009; 3071153; 3078041; 3078128; 3092028; 3106007. Canadian Market Lot Numbers: 3064125; 3071153; 3064279; 3071009; 3071153; 3064156; 3064182; 3064188.

Why it was recalled

39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

Root cause (FDA determination)

Other

Action the firm took

Trade and health care professionals were sent recalled letters dated 1/29/2004.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2004-01-29
Posted by FDA: 2004-07-20
Terminated: 2004-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.