ARKRAY Statement Regarding U.S. Food and Drug Administration’s Public Health Notification: Potentially Fatal Errors With GDH-PQQ Glucose Monitoring Technology
EDINA, Minn., Aug. 14 /PRNewswire/ — ARKRAY, Inc., today announced that its line of GLUCOCARD and Assure blood glucose meter test strips do not use GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone), which the FDA has stated can falsely elevate blood glucose results in patients who are using certain therapeutic products.
The GLUCOCARD 01 and Assure families of products use a glucose-specific enzyme and can, therefore, distinguish between glucose and other sugars. In light of the FDA’s announcement, ARKRAY will upgrade any consumer concerned about their GDH system to a product from the GLUCOCARD 01 family at no charge. For more information, visit www.glucocardusa.com or call 800-566-8558.
“We’re very proud of our track record of safety and accuracy for our entire line of blood glucose monitoring products,” said Jonathan Chapman, president of ARKRAY, USA. “ARKRAY is focused on developing safe, reliable and effective products and committed to patient safety. All of ARKRAY’s blood glucose meters adhere to FDA requirements and are among the safest and most accurate on the market.”
About ARKRAY USA
ARKRAY, the world’s 5th largest manufacturer of diabetes self-monitoring systems, has been a pioneer for nearly 50 years in the field of automated analysis from laboratory and point-of-care systems to home use patient self-testing systems. ARKRAY’s primary focus throughout that time has been diabetes, developing the world’s first hand held blood glucose meter (late 1960s) and the world’s first HbA1c analyzer (1982). ARKRAY is one of the few diabetes testing companies in the U.S. market today that undertakes in-house each step of the development process to bring products to market. ARKRAY is among the leading medical device companies noted for their patent-based intellectual property by Patent Board (Wall Street Journal 6/17/08). Worldwide, ARKRAY is the fifth largest blood glucose meter manufacturer. For more information, visit www.arkrayusa.com.
SOURCE ARKRAY, Inc.