Events

Recall of 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.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28391
  • Event Risk Class
    Class 2
  • Event Number
    Z-0763-04
  • Event Initiated Date
    2004-01-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31751
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    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

BD Test Strips. || The US market BD Test Strips are identified by Catalog Numbers 322027 (50 coun...
  • Model / Serial
    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.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA