Roche Diagnostics Recalls some ACCU-CHEK Aviva Meters
Roche Diagnostics recalls some of its ACCU-CHEK Aviva glucose meters for diabetes patients “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.” In the US, the recall includes serial numbers 52500000000 through 52510999999. Organizations who have a meter with these serial numbers should contact 1-800-440-3638 for a product replacement. Outside the U.S., the recall includes serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999, and 52800000000 through 52810999999 (see also the Accu-Check web site). The recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips.
The Accu-Chek Aviva was first cleared by the FDA in May 2005 and its introduction on the US market dates from last August. A similar recall was issued by the company on November 11, 2005 but apparently only listed US serial numbers.
January 16, 2006 Related topics: Product Recalls, Quality, Safety, Errors