Class 2 Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System

• Date Initiated by Firm: June 22, 2015
• Date Posted: August 29, 2015
• Recall Status: Terminated on May 23, 2016
• Recall Number: Z-2482-2015
• Recall Event ID: 71611
• 510(K)Number: K111268
• Product Classification: Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
• Product: 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.
• Code Information: SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
• Recalling Firm/ Manufacturer: Bayer Healthcare, LLC; 430 S Beiger St; Mishawaka IN 46544-3207
• For Additional Information Contact: Customer Service; 800-348-8100
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 5 million bottles of control solution
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJX and Original Applicant = BAYER HEALTHCARE