BAYER HEALTHCARE, CONTOUR BLOOD GLUCOSE METER INFORMATION

July 2007

Bayer HealthCare Diabetes Care would like to ensure you are aware of a Bayer Contour Blood Glucose Monitoring System meter recall in Canada that began on June 6, 2007.  This recall was specific to Canada; there was no recall of meters in the United States. 

Our packaging supplier did not reconfigure 100% of the Canadian meters to Canadian measurements of mmol/L and as a result 33 new Contour meters set in the wrong units of measure for Canada were recalled.  The meters were sent to Canada in the U.S. units of measure (mg/dl). 

Bayer Diabetes Care was concerned that meters in the wrong units of measure could lead to a health risk. Of the thousands of new Contour meters sent from our contract packager over the last six months, 33 were not properly configured.  (Canada uses mmol/L and these 33 meters, in particular, were in mg/dL, which is a setting used in the U.S.)  Seventeen of the meters were still under Bayer control, sixteen meters were distributed to dealers and sold to customers.  At this time, all but two of the16 meters have been found and traded out for the correct meters

Patient safety is Bayer Diabetes Care’s highest priority and as such the recall was reported to both the FDA and Canadian officials.  To ensure this small Canadian meter recall does not impact the U.S. business, we have doubled our commitment to quality.  In fact, we are working with the supplier to put additional processes and quality checks in place to assure this does not happen again in any market.

For more information on the Bayer Contour Blood Glucose Monitoring System, please visit www.bayerdiabetes.com/us.  If you wish to request further information, please contact us at (914) 366-1738.

Sincerely,

Wilson Ford
VP, Quality Assurance/Regulatory Affairs
BHC Diabetes Care