Roche Diagnostics Recalls Some of its ACCU-CHEK® Aviva Meters in the U.S. Due to a Potential Electronic Malfunction
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.
For more information please contact:
Doyia Turner
Corporate Communications
Roche Diagnostics
Phone 317-521-7252
Cell: 317-694-0335
Doyia.turner@roche.com
posted by Schmid | 9:55 PM
20 Comments:
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