FDA Device

Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)

Hazard

Incorrect patient blood glucose test results may be reported due to a software problem.

What You Should Do

Remedy

Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.

Products

Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)
Brand
Roche Diagnostics Corp.
UPC
Aviva meter serial numbers 52500000000 through 52510999999.