Indianapolis, November 11, 2005
Roche Diagnostics Recalls Some of its ACCU-CHEK® Aviva Meters in the U.S. Due to a Potential Electronic Malfunction
In cooperation with the U.S. Food & Drug Administration, Roche Diagnostics has voluntarily sent people with diabetes, physicians, and pharmacists a letter informing them of a recall of some of its ACCU-CHEK® Aviva blood glucose meters, due to a potential electronic malfunction which will cause the meter to render itself inoperable or may cause the meter to show an erroneous result. This issue applies to ACCU-CHEK Aviva meters with serial numbers 52500000000 through 52510999999. Aviva test strips are not affected by this recall. To date, no adverse event has been confirmed in the United States, in relation to this issue.
People with diabetes, health care professionals, pharmacists, and distributors have been instructed that if they have a meter with these serial numbers, they should contact 1-888-591-5084 for a complimentary product replacement. This information is also available on the ACCU-CHEK website at www.accu-chek.com.
"Patient safety is our number one priority. This is why we are alerting people with diabetes and their healthcare providers of this potential electronic malfunction and voluntarily removing the potentially impacted meters from the market, despite the extremely low occurrence." said Don Dumoulin, Senior Vice President of U.S. Diabetes Care at Roche Diagnostics.
Roche Diagnostics launched the ACCU-CHEK Aviva meter in the U.S. in August of 2005. It is estimated that there are 150,000 ACCU-CHEK Aviva meters with these serial numbers currently in the U.S. market, and that a very low portion of these could experience an electronic malfunction.
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Last Updated: Saturday November 19, 2005 20:33:48
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