A Medical Device Daily
Roche Diagnostics (Indianapolis) said this week that it initiated a worldwide voluntary recall of specific Accu-Chek Aviva meters because of the potential for an electronic malfunction that can cause the meter to report an erroneous result or shut down and no longer be used.
The company launched the Accu-Chek Aviva meter in the U.S. last August. It estimated 150,000 of these meters in the U.S. market with these serial numbers.
The recall includes U.S. serial numbers 52500000000 through 52510999999.
The recall does not apply to meters with U.S. serial numbers 52511000000 and higher or Accu-Chek Aviva test strips, the company said.
Outside the U.S., the recall includes serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999, and 52800000000 through 52810999999. Customers outside the U.S. also have been notified.
The company said that only these recalled meters have the potential to experience this electronic malfunction.
To date, the company said three customer meter malfunctions have been confirmed in the U.S. and five outside the U.S.
Roche said it has notified the FDA and foreign governments concerning this recall.