Recalls / —

—#42785

Product

Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (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

For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.

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 #42785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.