Recall Information

Roche Diagnostics has become aware that some vials of ACCU-CHEK Comfort Curve and ACCU-CHEK Advantage test strips have small strands of plastic at the top of the vial that potentially prevent a proper seal between the vial and vial lid. The vial lid is designed to keep out air and moisture. Over time, these plastic strands can allow leakage of air and moisture into the vial which can in turn cause the test strips to retain moisture, potentially leading to a wrong result.

Test results may be erroneously high (up to 250 mg/dL above the true value) or low.

Action Required

If you use ACCU-CHEK Comfort Curve or ACCU-CHEK Advantage test strips to test your blood glucose, you must examine your test strip vials to determine if you have affected product. If you are visually impaired or otherwise have trouble seeing a small strand, ask a friend or family member to look for you.

If your test strip vial has a plastic strand at the top of the vial, do not use the test strips from the affected vial and immediately contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for replacement test strips.

As directed in the test strip package insert, you should always perform a test with control solutions when opening a new vial of test strips, or if your results do not match the way you feel.

Potentially Affected Test Strips

All ACCU-CHEK Comfort Curve and ACCU-CHEK Advantage test strips are potentially affected by this issue; however, the number of test strip vials with strands attached to the rim is low. If you open a vial with a strand attached to the rim, do not use the test strips from the affected vial. Immediately contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for replacement test strips.

Summary of Actions Required

• Immediately examine your vials of test strips to determine if there are any strands on the rim of the vials. If strands are present, immediately discontinue use of any test strips from the affected vial and contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for replacement test strips.
• If you have any questions about how to look for strands on the rim of the vial, contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.
• File this Urgent Product Recall for future reference.

Unusual Test Results

If at any time your result doesn’t match the way you feel, Roche Diagnostics recommends that you follow these steps:

1. Run a control test. (See your meter’s User Manual for instructions.)
2. Repeat a blood sugar test. (See your meter’s User Manual for instructions.)
3. If your blood sugar results still don’t reflect the way you feel, call your doctor immediately.

For proper use and updated product information, carefully review the test strip insert provided with each package of test strips.

Symptoms of High or Low Blood Sugar
Being aware of the symptoms of high or low blood sugar can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms.

High blood sugar (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, general aching, or vomiting.

Low blood sugar (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness around mouth or fingertips.

Please note: Not all people with high or low blood sugar will have symptoms.

Questions
This notification is being made with the knowledge of the Food and Drug Administration (FDA). If you have any questions regarding the information contained in this Urgent Product Recall, please contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

Roche Diagnostics Corporation
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA

Tel.+1-800-428-5074

ACCU-CHEK, COMFORT CURVE, and ADVANTAGE are trademarks of Roche.