Roche Diagnostics and the FDA have notified healthcare professionals of a worldwide voluntary recall of specific Accu-Chek Aviva Meters used to measure blood sugar levels, 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. This recall does not apply to meters with U.S. serial numbers 52511000000 and higher or Accu-Chek Aviva test strips. For more information, visit http://www.fda.gov/medwatch/safety/2006/safety06.htm#accu-chek.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.