Recalls / —

—#42607

Product

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

FDA product code

LFR — Glucose Dehydrogenase, Glucose

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K043474

Affected lot / code info

Aviva meter serial numbers 52500000000 through 52510999999.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.

Timeline

Recall initiated

2005-11-09

Posted by FDA

2006-01-24

Terminated

2007-06-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.