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

Roche Diagnostics has initiated a worldwide voluntary recall of specific ACCU-CHEK Aviva Meters (for blood glucose monitoring) 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 ACCU-CHEK Aviva meters were launched in the U.S. in August of 2005. It is estimated that there are 150,000 ACCU-CHEK Aviva meters with affected 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.

For a complete report of this update, please refer to:

http://www.fda.gov/oc/po/firmrecalls/roche01_06.html

If you have any comments regarding this update, please email: info@mdiconsultants.com

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