Jan. 20, 2006 --The FDA and Roche Diagnostics have announced a voluntary worldwide recall of specific Accu-Chek Aviva meters, which are used by people with diabetes to measure blood sugar levels.
The recall is due to the potential for the meters to have an electronic malfunction, which can cause incorrect readings or make the meter shut down and become unusable.
The recall only applies to meters with certain serial numbers. "Only the recalled Accu-Chek Aviva Meters have the potential to experience the electronic malfunction," states an FDA news release.
The serial number is found 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," states Roche Diagnostics, manufacturer of the meters, in a news release posted on the FDA's web site.
In the U.S., the recalled serial numbers range from 52500000000 through 52510999999. Outside the U.S., the recall includes:
- Serial numbers 52600000000 through 52610999999
- Serial numbers 52700000000 through 52710999999
- Serial numbers 52800000000 through 52810999999
The recall does not apply to meters with U.S. serial numbers 52511000000 and higher, or to Accu-Chek Aviva test strips, states Roche Diagnostics.
Roche Diagnostics will replace the recalled meters and asks patients, health care workers, pharmacists, and distributors with recalled meters to call (888) 591-5084 for a product replacement.
Roche Diagnostics, which launched the Accu-Chek Aviva meter in the U.S. in August 2005, estimates that there are 150,000 Accu-Chek Aviva meters with the recalled serial numbers in the U.S.
The firm's news release states that as of Jan. 16, there were three confirmed reports of meter malfunctions in the U.S. and five cases in other countries.
Roche Diagnostics asks U.S. consumers with general questions about the meters to call the Accu-Chek Customer Care Service Center at (800) 858-8072. U.S. health care workers may contact a different Accu-Check phone number: (800) 440-3638.