Events

Recall of Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System

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

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
    71611
  • Event Risk Class
    Class 2
  • Event Number
    Z-2482-2015
  • Event Initiated Date
    2015-06-22
  • Event Date Posted
    2015-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138386
  • 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
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • Reason
    If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.
  • Action
    On 6/22/2015, Bayer Healthcare began sending URGENT - MEDICAL DEVICE FIELD CORRECTIVE ACTION notifications to affected Health Care Providers, Pharmacies, and Users. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are instructed to always check the expiration, not to use and discard of expired control solutions. Also, only CONTOUR NEXT control solution should be used with the CONTOUR NEXT test strips. The control solution bottle should be shaken about 15 times before each use. The letter instructed customers to refer to their meter's user guide for further testing instructions. If test results outside the control range are received, another test should be performed following the instructions provided in the letter. If the problem persists, customers should contact Bayer Diabetes Support. Bayer will replace the control solution or provide new control ranges for the test strips, depending on the situation. The firm has implemented improvements to provide more consistent control solution product.

Device

Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System
  • Model / Serial
    SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.
  • Product Description
    Contour Next Control Solution for Contour Next Blood Glucose Test System. || Liquid quality control solution. Plastic bottle, 2.5mL. || Indicated for use with fresh fingertip capillary whole blood samples.
  • Manufacturer
    Bayer Healthcare, LLC

Manufacturer

Bayer Healthcare, LLC
  • Manufacturer Address
    Bayer Healthcare, LLC, 430 S Beiger St, Mishawaka IN 46544-3207
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA