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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System see related information
Date Initiated by Firm June 22, 2015
Date Posted August 29, 2015
Recall Status1 Terminated 3 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/
Bayer Healthcare, LLC
430 S Beiger St
Mishawaka IN 46544-3207
For Additional Information Contact Customer Service
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 2
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