Events

Recall of Device Recall MediSense Precision Glucose Test Strips.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AmeriSource Bergen.

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
    28208
  • Event Risk Class
    Class 2
  • Event Number
    Z-0596-04
  • Event Initiated Date
    2004-01-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31379
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Reason
    Potential counterfeit product/box.
  • Action
    The recalling firm issued a recall letter to their direct accounts informing them of the problem and the need to return the product.

Device

Device Recall MediSense Precision Glucose Test Strips.
  • Model / Serial
    Lot number 89873 exp 4/30/04, Lot number 90524 exp. 11/30/04, Lot number 90848 exp. 1/31/05, Lot number 90891 exp. 1/31/05, and Lot number 91326 exp. 3/31/05.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to retail and hospital pharmacies nationwide, Puerto Rico and the Bahamas.
  • Product Description
    MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.
  • Manufacturer
    AmeriSource Bergen

Manufacturer

AmeriSource Bergen
  • Manufacturer Address
    AmeriSource Bergen, 1300 Morris Drive, Chesterbrook PA 19087-5594
  • Source
    USFDA