Roche Diagnostics Issues a Worldwide Voluntary Recall of Some of its ACCU-CHEK Aviva Meters

The Food and Drug Administration (FDA) released the following information:

Contact:
Doyia Turner
317-521-7252

Roche Diagnostics has initiated a worldwide voluntary recall of specific Accu-Check Aviva Meters because of the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used.

The recall includes U.S. serial numbers 52500000000 through 52510999999.

In the U.S. 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 product replacement.

The recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips. This information is also available on the ACCU-CHEK website at www.accu-chek.com.

Outside the U.S., the recall includes serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999, and 52800000000 through 52810999999. Customers outside the U.S. have also been notified.

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 only these recalled ACCU-CHEK Aviva meters have the potential to experience this electronic malfunction. To date, 3 customer meter malfunctions have been confirmed in the U.S., in relation to this issue and 5 outside the U.S.. The FDA and foreign governments have been apprised of this voluntary recall.

Accu-Chek Aviva meters were distributed to wholesale and retail distributors throughout the U.S. They can be identified by reviewing the serial number located on the back of the meter. If the serial number falls within the range of 52500000000 through 52510999999, it is potentially affected and therefore subject to this recall.

Roche Diagnostics has notified its distributors and registered customers in the U.S. by mail and is arranging for replacement of the recalled products.

In the U.S., consumers with general questions may contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 and health care professionals may contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638.


Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.